Drug Safety Resume Samples

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T Ruecker

Trystan

Ruecker

92258 Jayde Viaduct

Houston

+1 (555) 109 5813

92258 Jayde Viaduct

Houston

Phone

p +1 (555) 109 5813

Experience Experience

Chicago, IL

Drug Safety Physician

Chicago, IL

Homenick, Rath and Jones

Chicago, IL

Drug Safety Physician

Writing individual case assessments and interpreting aggregate safety data for periodic reports
Medically review individual adverse event reports with assigned products, both from clinical trials and post-marketing, for seriousness, expectedness and causality
Identify and assess potential safety signals for Ironwood products, and communicate to the Safety Review Committee
Collaborate with Business Partners, on the exchange of safety data, safety monitoring and safety profile, as laid out in Pharmacogivilance Agreements
Draft Analysis of Similar Events for SUSARs, and aggregate reports as necessary; review and approve Investigator Safety Letters
Draft Development Safety Update Reports (DSURs) and Post-Marketing Periodic Safety Updates (PSURs) as necessary
Provide medical safety input for Investigator's Brochures, IND and NDA submissions, Product Labels, MAA Annual Safety Reports and other regulatory documents and communications

New York, NY

Drug Safety Coordinator

New York, NY

Grimes, Dooley and Lueilwitz

New York, NY

Drug Safety Coordinator

Provide input and review of relevant safety tracking systems for accuracy and quality and assist with maintaining project files
Assist management with weekly and monthly project status reports
Perform safety review of clinical and diagnostic data
Work effectively within a team environment
Recognize, exemplify and adhere to ICON's values which centers on our commitment to People, Clients and Performance
Actively identify out of scope activities in conjunction with the MSS Functional Lead and/or ICON Project Manager
Assist the MSS Functional Lead (e.g. Medical Monitor) independently

present

Chicago, IL

Drug Safety Manager

Chicago, IL

Jacobi-Bayer

present

Chicago, IL

Drug Safety Manager

present

To assist senior management with resourcing and business development activities, including attendance at bid defense meetings as requested
Assist upper management with resourcing and business development activities
Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
Performing continuous quality improvement initiatives to ensure data consistency and a high level of data quality
Develop and implement department training
Provide safety review of clinical study documents, including protocols, study reports; and marketing application components
Assist with maintenance of project budgets and oversight by identifying out of scope activities

Education Education

Bachelor’s Degree in Life Sciences

Ashford University

Bachelor’s Degree in Life Sciences

Skills Skills

Bounces back quickly from disappointments and mistakes; learns and moves on quicklyR&D
Able to prioritise and manage own workload autonomously
Excellent communication skills both written and oral
Seeks opportunities to learn and grow professionally
High level of accuracy and attention to detail
Flexible and adaptable team player
Self-motivated
Actively seeks feedback, appreciates and uses constructive criticism
Passion for working in the pharmaceutical industry

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15 Drug Safety resume templates

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Drug Safety Physician Resume Examples & Samples

Medical degree with US board certification and license to practice medicine
Assessing seriousness, expectedness and comparing causality and queering for additional medical information needed to understand the event and determine causality
Writing individual case assessments and interpreting aggregate safety data for periodic reports

Drug Safety Case Manager Resume Examples & Samples

Handling (Triage, Data Entry, Quality Control) of any new ICSR or follow-up of previously received ICSR related to any medicinal products (both spontaneous post marketing and clinical trial ICSR belonging to the CDS European Group)
Maintaining Pharmacovigilance systems in compliance with Company procedures and regulatory obligations
Coding of Adverse reactions using MedDRA
Coding of drugs using WHO drug dictionary
Writing case narratives
Retrieving follow up information as required
Electronic reporting (Eudravigilance) of same to EMA and National Agencies in accordance with regulatory requirements
Timekeeping, attendance and general reliability
Work output - The ability to self manage and achieve defined objectives
Quality of workmanship
Technical Competence
Compliance with Company Health & Safety, Environmental and Quality practices
Positive work attitude and the fostering of effective working relationships with colleagues, customers and management team - An effective team player, working to company goals
Contribution to improving departmental efficiencies
Training and self-development
SOP Management to include authoring, review and processing updates/revisions
Reviewing and Updating Drug Safety Exchange Agreements
Aggregate Report Preparation (PSURs, DSURs etc)

Drug Safety Operational Analytics & Process Excellence Lead Resume Examples & Samples

7-8 years of pharmaceutical experience
Drug Safety experience
Professional attitude
Proficiency with computer platforms and applications
Demonstrable leadership skills

Global Drug Safety Process Resume Examples & Samples

50%:Manage creation/revision of assigned procedural documents including cross-functional documents. Liaise with GDS and cross-functional subject matter experts as necessary. Maintain department-specific documentation in support of the PV system in a document management system as directed
20%: Design, develop, implement, and facilitate training on Pharmacovigilance topics and GDS procedures as needed including appropriate documentation
10%: Evaluate legislation and guidance related to pharmacovigilance system. Work with SMEs to identify gaps with current process. Present gaps as well as potential solutions to management. Ensure changes to legislation are reflected timely in GDS process documents
10%:Manage curriculum for GDS staff and work with the PST team to remediate any gaps or issues. Develop evaluation and assessment strategies for the department learning objectives. Continually assess department training needs to identify areas for improvement. Maintain and conduct new hire on-boarding activities
10%:Manage special process or training related projects as directed by Head of GDS PST
Bachelors of Science degree preferred in medical or science-related field
5+ years in pharmaceutical industry preferably in pharmacovigilance, QA, clinical development, or similar department
3+ years’ experience procedural document creation or revision
Strong understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
Strong project management skills required
Practical experience in the interpretation of PV regulations and implementation
Technical expertise with databases (Access, TrackWise, Argus, etc.) and document management systems
Knowledge of Quality Management Systems, FDA/EU regulations and ICH guidelines for GVP and GCP

Business Objects With Drug Safety Resume Examples & Samples

Strong communication skills a must; strong organization skills essential
Five plus (5+) years of experience with SAP Business Objects software (XI 3.1 and 4.2)
Bachelors degree or equivalent
Knowledge of Drug Safety/Pharmacovigilence
Ability to work and contribute in a team environment
Responsible for collaborative analysis, design, build and execution of Business Objects reports for safety activities (PSURs, PBRERs, DSURs, Safety Topic Reviews)
Overseeing and managing the delivery of scheduled reports for the Global Safety Network of Drug Safety Professionals
Assisting in the maintenance of users access to Drug Safety reporting environment
Reviewing and contributing to the preparation of reporting manuals and report design specification documents
Performing manual data review and Quality Control activities by reconciling quality control findings

Director of Drug Safety Clinical Development Resume Examples & Samples

Develop PV system to house, track and report safety events for all Aduro products, including evaluation and implementation of global safety database
Manage safety surveillance for assigned compounds / products
Manage compilation of current data for safety signaling and identify and investigate safety signals in collaboration with study Medical Monitor(s)
Develop drug safety standard operating procedures (SOPs) and processes
Conduct review and analysis of safety data from ongoing trials
Supervise clinical safety services outsourced to contract research organizations (CROs), independent contractors, and other vendors. This may include the development of Safety Management Plans covering study-specific SAE workflow between CROs/vendors and Aduro
Ensure adequacy and consistency of recording, summarizing, and handling of adverse events for Aduro products including decisions on seriousness, expectedness, and causality
Develop, review, and provide input to safety sections of clinical and regulatory documents, e.g., Investigator’s brochures, protocols, IND annual reports
Prepare safety summaries for clinical & regulatory documents
Develop safety narratives and analysis of similar events (in collaboration with Medical Director) for safety reports
Provide safety strategic leadership for clinical development programs / program teams, including input into safety monitoring requirements for clinical programs based on product safety profile
Collaborate with pharmacovigilance (PV) and drug safety colleagues from partner companies to develop PV agreements and adhere to them
Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities
Minimum of 7 years industry experience in Safety and Pharmacovigilance
Relevant early phase oncology and/or immuno-oncology experience required
Knowledge of pre- and post- marketing US and EU safety reporting regulations
Knowledge of clinical pharmacology highly desirable
Demonstrated sense of urgency and accountability for both individual and team-owned work products
Ability to work in a fast-paced, entrepreneurial environment
Pharmacovigilance, Drug Safety; 7+ years experience
Advanced Degree (MD, PhD, Pharm D, RN)

Director, Drug Safety Physician Resume Examples & Samples

Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports
Contribute to ongoing safety surveillance and signal detection efforts
Contribute to the identification, assessment and communication of potential safety signals
Contribute to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for assigned products, and the maintenance of these documents
Present safety data and results
Collaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials
Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups
Medical Degree (MD) from recognized medical school with at least four years of medical practice
Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
Demonstrated exposure to medical drug safety assessments, drug safety surveillance and monitoring activities
Experience with safety data collection and interpretation originating from clinical trials
Experience with the medical review of aggregate reports
Experience with the review of Reference Safety Information for drug safety purposes
Ability to build relationships and influence across disciplines

Drug Safety Manager Resume Examples & Samples

Safety Lead on programs
Attend clinical team meetings as safety representative
Oversight over ICSR case processing activities
Oversight of vendors and business partners
Oversight and support of reconciliation activities
Provide input on aggregate reports
Train to SOPs
Health authority responses - Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, DSUR/PSUR, or clinical study reports
This role is an individual contributor
A clinical degree (e.g., RPh/PharmD, BSN, RN )
5+ years drug safety or clinical safety experience
Two years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge
Ability to work effectively as an individual contributor and as project team member
Has the ability to work independently with minimal supervision, able to multi-task with attention to detail,

Drug Safety / PV Senior Scientist Resume Examples & Samples

Review of non-serious and serious AE’s and aggregate AE listings
Preparation of signaling meeting presentationsin collaboration with the team. Including review of events of interest, initial trending of AE’s, set thresholds for escalation and preparation of meeting minutes
Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation
Safety Committee preparation and documenting of meeting minutes
Urgent Safety Issues review and escalation to MD
Knowledge of MedDRA terminology and its application
Initial preparation of RMP, PV plans
Literature search terms and summary results review and escalation to MD
Clinical study (e.g. IB, NDA)– safety benefit-risk review; ad-hoc reports
Aggregate report review and input for assigned products such as PSURs, PBRER, PADER – triage to MD
Interact with vendor contracted to author aggregate reports for specific products , as needed
In collaboration with the team, contribute to and help coordinate responses to safety questions from regulatory authorities for assigned products
Contributes to initiatives for process improvement and consistency regarding aggregate reporting, signal management and responding to ad hoc safety questions
Other tasks as assigned or required
Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 year experience in PVG
Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts
Strong organizational skills, including the ability to prioritize independently with minimal supervision
Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems

VP, Drug Safety & PV Resume Examples & Samples

MD or equivalent
10+ years industry experience focused in Drug Safety/Risk Management/Pharmacovigilance
Experience building and managing teams
Experience in developing systems and processes for handling, processing, analysis and global regulatory reporting of adverse event reports, including serious adverse events
Previous experience in management of drug safety through all Phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds', and REMS
Intimate up-to-date knowledge of global safety reporting requirements from a regulatory perspective
Experience in managing significant accelerations and challenges in clinical programs
Outstanding leadership and collaboration skills working within a matrix environment
Comfort working with Senior Executive Team and on occasion with Board members, and other external audiences such KOLs, regulatory bodies, and investors
Superb presentation skills

EU Qppv & Drug Safety SME Resume Examples & Samples

Strong experience in Pharmacovigilance and Project Management
Experience in Drug Safety Applications and Regulatory compliance applications a plus
Knowledge of 21 CFR Part 11 guidelines, EMA GvP modules, Computer system validation guidelines
Experience in Service Delivery of Small, Medium and/or Large sized Drug Safety projects
Strong project management skills, with a keen desire for execution
Strong analytical and strategic thinking abilities
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross-department communication. Ability to document and communicate problem/resolution and information/action plans
Person should be familiar with Microsoft office applications such as MS word, Excel, PowerPoint, MS Access
Knowledge of ARISg or equivalent Drug Safety Database (ie ARGUS, AERS, etc.) a plus
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrated flexibility within a dynamic, fast-paced, cross-functional team
Demonstrated ability to complete multiple tasks concurrently and deliver results in a challenging environment
Must be a qualified healthcare professional (Md or PharmD)
Strong experience in Drug Safety operations and Project Management
Exposure to Sales activities a plus

Medical Director, Drug Safety Resume Examples & Samples

Provide safety strategic leadership for clinical development programs / program teams
Minimum 5 years experience in the pharmaceutical industry or clinical care setting
Knowledge of pre- and post- marketing US and EU regulations
Demonstrated strategic and critical thinking
Capacity and willingness to work effectively across disease areas
Demonstrated ability to work in an entrepreneurial culture

VP, Global Drug Safety & Risk Management Resume Examples & Samples

Oversee strategies for Celgene compliance with EMA or other relevant Regulatory Agencies on pharmacovigilance requirements gaining consensus within Global Drug Safety
Contribute to pharmacovigilance agreements with licensees & commercial agents
Ensure the management of local country office safety process and resources
Communicate with appropriate country office staff on safety issues
Higher degree in relevant medico-scientific field
Extensive proven relevant experience, including training at a similar, global level
Drug safety experience with specific experience of European Pharmacovigilance
Previous management experience (international preferred)
Mastery of global regulatory requirements for pharmacovigilance, emphasis on EU and EMEA
Organizational business administration
Issue management

Senior Drug Safety Analyst Resume Examples & Samples

A minimum of 3 years of experience in Drug Safety/Pharmaceutical industry and/or greater than 5 years of experience in a healthcare setting
Ability to work in intense, fast paced, matrixed, multinational work environment
Ability to effectively communicate with employees, colleagues, and global counterparts
Positive motivator

Associate Manager, Drug Safety Operations Resume Examples & Samples

Will provide leadership to the Intake Team
Will be responsible for the oversight of all Intake reconciliation activity and correspondence with the Standards & Collaborations team
Will have people management responsibilities: provide management support and guidance to the team of Safety Associates and Safety Specialists. Responsible for supervision and performance reviews
Independently establishes work priorities and direction with minimal input from Manager
Will have data review responsibility, to ensure data entries made by Intake Team are accurate
Will interact with other Drug Safety functional areas to register/import adverse events cases efficiently and reliably
Identifies issues/concerns in a timely and appropriate manner and provides possible solutions. Remain current with case handling SOPs, guidance documents and database technology
Work with Lead Intake Specialists on daily assignments and projects
Oversees all activities or responsibilities that are delegated to junior staff members and ensure quality and accuracy of deliverables, and ensure deadlines are met appropriately
May participate in assigned projects such as inspection readiness activities or inspection interviews
5+ years of drug safety/drug development or relevant experience, preferably in both clinical and post-marketing environment and a BS degree in a related science

Drug Safety Manager Resume Examples & Samples

As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (up to approximately 15%) domestic and/or international as applicable
Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
Keep management appraised of any potential/actual study or staffing issues and develop solutions for same
Develop and implement department training
Assist in training of other departments, as requested
Assist with maintenance of project budgets and oversight by identifying out of scope activities
Assist upper management with resourcing and business development activities
Attend bid defense meetings, as requested
Manage small to mid-size drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
Ensure audit readiness and/or MSS representation at audits
Develop safety plans, study specific procedures, and workflows for clients, as requested
Actively identify options for process improvement
Supervise maintenance of project drug safety files as regionally applicable
Perform other activities as identified and requested by management
Manage REG GRA projects in accordance with established timelines , budget, quality standards and/or contractual requirements
Develop supporting staff skills, encourage growth and provide regular performance feedback
Provide project and/or line management of assigned REG staff
Serve as a mentor and role model for REG staff

Drug Safety Coordinator Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which centers on our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (up to approximately 10%) domestic and/or international as applicable
Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
Provide input and review of relevant safety tracking systems for accuracy and quality and assist with maintaining project files
Perform safety review of clinical and diagnostic data
Serve a resource for investigational sites and ICON personnel on safety-related issues
Train/mentor newly hired DSA staff, as requested
Liaise with Sponsor and attend Sponsor meetings, as required
Generate study specific procedures for contracted departmental services
Assist management with weekly and monthly project status reports
Assist with generation of regulatory reports as necessary to ensure regulatory compliance
Conduct safety presentations for start-up meetings, Investigator meetings and other meetings
Serve as lead DSA on all (including global) medical or safety projects as assigned
Assist the MSS Functional Lead (e.g. Medical Monitor) independently
Coordinate interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)
Actively identify out of scope activities in conjunction with the MSS Functional Lead and/or ICON Project Manager
Provide in-depth technical expertise
Review SSPs, maintain appropriate documentation, and liaise with ICON QA department as necessary, prior to management review and approval of SSPs
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (US)
US/LATAM/CAN: A minimum of 3 years of relevant clinical research / pharmaceutical industry experience, preferably in pharmacovigilance / drug safety
EU/APAC: Significant relevant clinical research / pharmaceutical industry experience, preferably in pharmacovigilance / drug safety
Clearly demonstrates professional demeanour, judgement, and discernment in interactions with colleagues, clients and other ICON staff
Good knowledge of medical terminology and coding systems
Very good computer skills (Microsoft Word, Excel, Outlook, Access)
Good ability to mentor staff
Ability to work independently or lead study teams
Work effectively within a team environment
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Drivers license

Drug Safety Project Lead Resume Examples & Samples

Lead projects and take on project management activities
Prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, and Principal Investigators and business partners
Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials
Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors
Serve as support to Safety Reporting Group management in all aspects of departmental activities , as needed
Serve as technical expert with regard to all aspects of safety reporting
The successful candidate will have significant relevant clinical research/pharmaceutical industry experience, in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems
Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment
Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent

Drug Safety Manager Resume Examples & Samples

To keep senior management appraised of any potential or actual study/staffing issues and develop solutions for the same
To project manage small to mid-size drug safety projects, including sponsor liaison, management of quality standards/timelines/budgets and development of safety plans, study specific procedures (SSPs) and workflows for clients
To assist senior management with resourcing and business development activities, including attendance at bid defense meetings as requested
To ensure audit readiness and/or represent MSS at audits
To actively identify options for process improvement and develop/implement departmental training to develop supporting staff skills, encouraging growth and providing regular performance feedback
The successful candidate will have advanced, proven relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems as well as contract and proposal preparation/review
Proven ability to lead study teams and manage/mentor staff
The ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors and sponsors. Must be fluent in written and verbal English with good communication skills and excellent computer skills. Detail orientated and capable of working effectively within a team environment

Senior Manager, Corporate Drug Safety Resume Examples & Samples

Review the case processing of external vendors to ensure high quality reporting of all source information received on adverse events and successful electronic transmission of regulatory submissions
Ensure timely submissions of all safety reports within mandated timelines to US FDA and others, as needed
Review aggregate reports and finalize content for regulatory submission
Mentor/instruct and provide guidance to direct reports and/or junior staff (as applicable)
Support risk management group with interim reports and maintenance of risk management plans
Write adverse event related sections of aggregate reports
Support any third party relationships by creation, review and/or approval of safety data exchange agreements, as applicable. Ensure all agreements are executable and compliant with all applicable laws and regulations
Perform reconciliation of adverse events with third parties and external vendors
Maintain and improve (as needed) guidelines, policies and procedures for the department
Bachelor’s degree and health care disciplines, e.g. RN/BSN, PharmD, RPh. PA
5-8 years’ experience with drug safety and pharmacovigilance
5-8 years’ experience proficiency with drug safety databases and pharmacovigilance regulations
History of health case licensure and/or certification

Drug Safety Physician Resume Examples & Samples

Medically review individual adverse event reports with assigned products, both from clinical trials and post-marketing, for seriousness, expectedness and causality
Identify and assess potential safety signals for Ironwood products, and communicate to the Safety Review Committee
Collaborate with Business Partners, on the exchange of safety data, safety monitoring and safety profile, as laid out in Pharmacogivilance Agreements
Draft Analysis of Similar Events for SUSARs, and aggregate reports as necessary; review and approve Investigator Safety Letters
Draft Development Safety Update Reports (DSURs) and Post-Marketing Periodic Safety Updates (PSURs) as necessary
Provide medical safety input for Investigator's Brochures, IND and NDA submissions, Product Labels, MAA Annual Safety Reports and other regulatory documents and communications
Review and approve safety sections of clinical trial protocols, analysis plans, study reports
Closely collaborate with Clinical Operations, Safety Operations and Regulatory Affairs for seamless PV processes
Collaborate with clinical trial directors for safety monitoring
Board certification or eligibility and subspecialty training would be a plus, but is not required
Be familiar with quantitative methods, experience in epidemiology is a plus

Drug Safety Physician Resume Examples & Samples

Draft and review Medical Risk Assessments
Author and/or review signal management reports
Draft and/or review periodic reports (i.e., PADERs, PSURs, and PBRERs) for submission to the health authorities
Assist with the development, implementation and/or daily management of Risk Evaluation and Mitigation Strategies and Risk Management Programs
Assist with the review of promotional materials prior to distribution
Provide medical guidance to assigned projects and internal stakeholders on clinical expertise matters
Review regulatory letters and correspondence while acting as departmental point of contact for internal inquires
Perform medical review of adverse event cases with the Mylan pharmacovigilance database
Requires medical (MD) degree and a minimum of 5 years of experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration
Must possess a strong clinical background. Must be familiar with electronic safety databases, coding dictionaries and query development as well as FDA, Health Canada, ANVISA regulations and guidelines
Must possess strong and effective communication and time management skills. Must possess good drug information research skills including the medical literature and be able to conduct on-line research. Must possess computer skills by using MS suite
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems
Periodic travel may be required
Proficiency in speaking, comprehending, reading and writing English is required

Drug Safety Operations Coordinator Resume Examples & Samples

Receipt and Triage of SAE reports
Demonstrated knowledge and understanding of domestic and international regulatory safety reporting requirements
Must have excellent organizational skills
Strong communications skills (verbal and written)
Junior level college degree or equivalent training
Ability to sit and type on computer keyboard for long periods of time

Manager, Case Management, Drug Safety Resume Examples & Samples

Supports Case Management team with all pharmacovigilance activities associated with Individual Case Safety Report (ICSR) processing and reporting of adverse events in accordance with local regulations and company procedures
Accountable for mentoring, coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development
Responsible for the performance of assigned personnel against departmental processes, standards and performance goals and for ensuring successful completion of all training required for the role
Author and review updates and new documents, processes or activities to create unified and consistent safety-related procedures within the department
Demonstrates seamless collaboration with other departments for delivery of drug safety services, process improvement initiatives and to provide guidance for cross-functional team activities
Assist with the preparation of safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, IND annual reports, integrated summaries of safety)
Provide general oversight to the management of outsourced data collection activities with CRO’s and lead preparation, review and approval of new or updated documentation to support standardizing outsourced activities (e.g. safety management plans and budgets)
Under the guidance of the manager will collaborate with corporate partners for clinical trial and post-marketing pharmacovigilance activities (i.e. pharmacovigilance agreements and safety management plans)
Contribute to the development and implementation of the strategic direction for case management functional team and department
Detail oriented with the ability and desire to work in a fast paced, team oriented small company environment with the ability to manage simultaneous priorities and challenging deadlines
Experience with the use of drug safety databases (e.g., Argus, ARISg, etc.)
BS Pharmacy, PharmD, BS RN degree with critical care management background preferred, MD or equivalent training
Six years’ experience in Drug Safety in a biopharmaceutical environment is preferred
Previous management experience preferred

Global Drug Safety Risk Management Team Lead Resume Examples & Samples

Responsible for the strategy and implementation of benefit-risk management for Shire products. Development of REMS, DRMP’s & RMP’s, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies
Actively participates in Benefit- Risk Committees and other safety committees as needed. Effectively manages the Benefit/Risk process
In support to the Head of Risk Management, supervises assigned team of Risk Management specialists for various therapeutic areas and/or products. Supervision and support includes but not limited to
Assignment of products and representation of Risk Management support within Global Drug Safety and Shire
Taking accountability while supporting the individual Risk Management specialist and assigned Risk Management team and multiple project deliverables
Supporting the Risk Management specialists in prioritization and expert advice for efficient planning for quality outputs
Reviewing work outputs, documents, etc. produced by the specialists and providing critical review and expert thinking before agreeing for further review by Global Drug Safety and other line functions
Providing back up support for the Risk Management Specialists and projects as needed
Mentoring and development of the Risk Management Specialists
Ensuring performance and alignment of personal and team roles to Global Drug Safety goals and objectives
Participating in further development of Risk Management and / or Global Drug Safety processes and outputs
Prepares and assists in the management of Risk Management project timelines. Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off. Ensure all regulatory commitments in RMP’s are followed & tracked
Represent Risk Management on cross functional teams and Interface with other Shire functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
Communicates effectively on product risks to senior management and the Office of the EU Qualified Person
Management of GDS- Internal Safety Review Committee and Shire’s highest safety governance Executive Safety Review Committee meetings
Provide advice and liases with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment
Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports. Ensures that the safety risks with Shire projects/products are identified promptly Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed
Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates Participate in other activities, teams and committees as assigned
MD, PhD or Pharm D with specialty training in functional area at least 10 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
At least 5 years of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
Ability to read and analyze scientific and medical literature
Ability to work with interdisciplinary, highly matrixed team
Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
Planning and Organizing
Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
Ability to establish and maintain professional communication both internally and externally with all stakeholders

Global Drug Safety Compliance Lead Resume Examples & Samples

Drives Pharmacovigilance compliance based on expectations and/or requirements of regulatory agencies, internal processes, and external business partner obligations
Evaluates responses and corrective and preventative action plans (CAPAs) to audit findings for adequacy and timeliness, reviews implementation, and manages the closeout of all corrective and preventative actions
Develop, evaluate and monitor internal/external compliance metrics
Alert management, including EU QPPV, of significant deficiencies in quality or compliance standards including proposed corrective/preventative actions
Monitors, reviews and makes recommendations regarding processes and guidelines with emphasis on compliance standards
Develop and execute method for tracking partner compliance to the safety agreement
Conduct internal assessment of Shire PV compliance with process and contractual obligations
Participate in business partner audits of Shire and support QA&C audits of business partners. Support regulatory inspections
Provides support during regulatory inspections at Shire
Work with key stakeholders to define and ensure compliance with global business and regulatory requirements
A minimum of 5 years prior experience in drug safety/pharmacovigilance in a global setting
Having worked internationally and in ex-US territories is a plus
Expert knowledge of global PV regulations

Global Safety Lead, Global Drug Safety Resume Examples & Samples

At least 5 years of experience with aggregate reporting, safety surveillance, signal management and/or Risk Management
At least 5 years of Clinical Patient Care experience preferred
Previous experience in bioscience preferred
Oral and written communication and interpersonal skills

Medical Director Global Drug Safety Resume Examples & Samples

Leadership of the Safety Review Teams for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)
Responsible for key content of Risk Management documents (RMPs, REMS)
Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required reports
Ensure communication of all safety issues that may impact the benefit-risk profile of assigned products/development compounds to Senior GDS management including making presentations to the Independent Safety Review Committee
At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or Risk management
Drug safety database knowledge preferred

Assoc Medical Director, Drug Safety Resume Examples & Samples

1) Manage safety surveillance for assigned compounds / products
2) Integrate the safety scientific component to build a strategic framework for clinical development plans
3) Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical
4) Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities
Benefit-risk related strategy experience required
Excellent communication skills (oral and written) and excellent organizational skills

Drug Safety Manager Resume Examples & Samples

Provide line management of Safety Regulatory Reporting staff assigned
Ensure all project safety activities are completed in accordance with SOPs, SSPs, and other applicable regulations
Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
Coordinate and implement department training and identify training needs; provide Safety Regulatory Reporting training to other departments as requested
Maintain quality review metrics and attend other project quality meetings as required
Serve as a mentor and role model for Safety Regulatory Reporting staff
Manage drug safety projects including Sponsor liaison, and management of timelines and budgets as appropriate
Ensure audit readiness and representation at audits
Medical /science background (nursing, pharmacy or medicine preferred) with relevant clinical experience, 5 years drug safety or equivalent experience; prior supervisory or mentoring experience
Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other ICON staff
Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or sponsors

Drug Safety Manager Contract Resume Examples & Samples

Oversight and project training of Safety Specialists
Performing continuous quality improvement initiatives to ensure data consistency and a high level of data quality
Work within cross-functional teams to ensure no issues within post-market and clinical trial activities
Review clinical trial reports
Support safety signaling information to PV Risk Management group
Author Safety Management Plans for assigned studies
Compile information for Safety Review Meetings and facilitate (weekly/monthly) meetings with project team (PV MD, Medical Monitor, Clinical Project Manager)
SME for audits and inspections
Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidances related to pharmacovigilance and Good Clinical Practices
Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
Competence with Argus commercial safety application database
Is proactive, demonstrate ability to independently identify problems and effectively offer solutions
Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints

Operations Specialist Drug Safety Resume Examples & Samples

Concise data entry covering everything from patient symptoms, admission and results – this will include medical terminology, writing narratives, generating case queries, performing quality control, and ensuring reports are sent to the customer within deadlines
Following up with the patient on topics including symptoms and medication to help identify if this is related to the drug programme
Collaborating with other functional groups within Lifecycle Safety and to ensure deliverables are met
Communicating with sponsors when required

Risk Management / Drug Safety Lead Resume Examples & Samples

Lead cross-function Safety Monitoring Team activities for assigned compounds
Represent Risk Management for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron
Actively participate in the development and maintenance of relevant SOPs and working practice
Contributes to the completion of organizational projects and goals

Director, Drug Safety & Pharmacovigilance Resume Examples & Samples

Minimum of 7 years PV/Drug/Device Safety experience
Minimum of 2 years managing cross functional projects
Expert-level knowledge of US, EU and other international PV regulations
Proven track record of effectively establishing processes and policies ensuring compliance with PV regulations, for both the investigational and post-marketing stages of drug development and commercialization
Experience in managing FDA and EMA HA Inspections and co-marketing partner audits Successful track record of managing FDA and EMA Inspections including interviews and providing inspectors with requested information or materials

Drug Safety Resume Examples & Samples

Support the coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable
Responsible for the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources
Assist with initial quality review and assessment of individual cases
Ensure availability as back-up for business and non-business hours contacts
Co-ordinate/perform the follow-up of missing information from the AE reporter
Assist in the provision of local data as required supporting the preparation of Safety Summary reports (PSURs, ASR, etc.)
Assist in the implementation of compliance standards and facilitate the collection of compliance metrics as required
Ensure that day-to-day Pharmacovigilance functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level
2 years of degree level study completed
A minimum of 2:1 achieved in first year of study
Bio science degree types only
Passion for working in the pharmaceutical industry
Seeks opportunities to learn and grow professionally
Able to prioritise and manage own workload autonomously
Flexible and adaptable team player
Actively seeks feedback, appreciates and uses constructive criticism
Bounces back quickly from disappointments and mistakes; learns and moves on quicklyR&D

Senior Associate, Drug Safety Quality Resume Examples & Samples

Drive a quality culture by the creation and tracking of Safety and Benefit Risk Management quality/compliance metrics as well as the development of quality dashboards / reports for dissemination to Senior Leadership and partners. Trend critical quality related issues such as Late Case Investigations
Oversee on-time Late Case investigations
Minimum of 3 years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences highly desired
Direct experience in GCP and GVP compliant quality systems

Intern, Drug Safety & Med Info Resume Examples & Samples

Support of the Drug Safety Specialist upon receipt and tracking of adverse events - this includes translations (German / English) with a; Archiving of non-adverse events (information that does not meet the minimum criteria for adverse events)
Preparing written follow-up requests (questionnaires that are sent to study centers and healthcare professionals to obtain further information about reported adverse events) including requests that were provided from employees on a global basis through the database ARISg
Support of the Drug Safety Specialist in the maintenance of the local and external archive and the data query system
Assist in the review of local literature regarding information on adverse events associated with a Celgene Product
Support in the processing of medical scientific questions
Literature searches using medical scientific databases
Creation of medical scientific information materials for distribution to professionals or for internal training purposes in the form of pesentation slides and texts
Strong identification with the values of Celgene
Completed second section of the Pharmaceutical Examination
Very good knowledge of German and good English language skills in written and spoken
Conscientious and reliable way of working

Drug Safety Physician Resume Examples & Samples

Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious)
Provide support to the Drug Information & Pharmacovigilance Product Support (call) Centre and the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile
Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON
Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
Review and provide input to the Project Specific Procedures and participate in project related meetings
Communicate with the client to an extent as described in the Project Specific Procedures
Provide assistance in the preparation and conduct of code-break activities
Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project

Drug Safety Physician Resume Examples & Samples

3) Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Worldwide Medical
Minimum 3 years’ experience in the pharmaceutical industry, clinical care setting, or Academia
Industry experience in early clinical development is highly desirable
Knowledge of clinical pharmacology and pre-clinical safety highly desirable
The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills

Drug Safety Manager Resume Examples & Samples

Assists with assessments of potential safety signals for safety physician review; involves synthesis of data from multiple sources and critical thinking skills as well as authoring monthly signaling reports
Prepare and author reports of aggregate safety data such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans
Key member of the Product Surveillance Team, including setting agenda, producing necessary data outputs, facilitating discussions, documenting conclusions
Works closely with SABR Clinical Trial Physicians and Global Safety Officers on data analysis, signal detection, ad hoc requests and other product activities, as assigned
Coordinates and authors responses to regulatory agencies in collaboration with safety physician; includes proposing a strategy for the response, review of relevant data, and authoring responses
Represents SABR and/or Pharmacovigilance on study teams, cross function product teams, etc
Supports safety activities for clinical trials, including protocol review, study team representation, document authoring, etc
This role can be based in Cambridge, Mass or Maidenhead, UK**
Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Able to develops and conduct, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests
Able to apply clinical judgment to interpret case information
Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes basic knowledge of case processing, expedited reporting rules, and safety database concepts
Strong organizational skills, including the ability to prioritize independently with minimal supervision
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems

Manager, Drug Safety & Pharmacovigilance Resume Examples & Samples

Manage drug safety/PV Vendors to ensure all internal and external timelines are met, potential issues are communicated and resolution is achieved in a timely manner
Maintain multiple internal tracking documents related to clinical trial and post-marketing SAE processing
Be responsible for collection, triage, process, review, and report of adverse event data in compliance with applicable FDA and global regulations as well as the Amicus SOPs
Closely monitor clinical trial and post-marketing case processing from receipt to case closure including query generation, narrative writing, data review and make accurate determination of significant information and identify and initiate requests for case follow up
Conduct complete review and assessment of all SAE reports. Ensure consistency in the initial evaluation and assessment of SAE reports and source documentation, prepare MedWatch, CIOMS, and other forms, as needed
Oversee SAE reconciliations for multiple studies, identify cases requiring investigator letters and draft investigator letters independently
Be responsible for reviewing and developing Drug Safety/Pharmacovigilance SOPs and Word Instructions and ensure safety operations are in compliance with the most current US and global regulations
Contribute to the development of risk management plans and REMs if needed. Support safety surveillance/pharmacovigilance activities
Review and revise safety-related sections in study protocols, periodic reports, Regulatory Agency submission documents
Review and revise SMPs, applicable SOPs and related forms
Assist in the preparation of safety sections for regulatory documents (e.g. DSUR, PBRER/PSUR)
Review and process contracts and change orders
Participate in signal detection and signal management activities
Ensure all safety-related documentation is properly filed (e.g. in the TMFs and the safety files)
Organize/participate in periodic Safety data review meetings (DSMBs, internal)
Maintain a high level of understanding of applicable Regulatory regulations (FDA and ICH guidance, GCP regulations; EU Directives, PVG Modules, etc) to assist in ensuring all requirements are adhered to
Maintain thorough familiarity with Amicus SOPs and study SMPs to ensure internal and external processing requirements are adhered to
Interact with other departments (e.g. Regulatory Affairs, Clinical Operations and Data Management, QA, and when required, Site Personnel) to ensure all safety reports are completed and submitted in time anbd in accordance with internal SOPs and external Regulatory reporting timelines
Minimum 5 years pharmaceutical or CRO experience in a clinical research or clinical trial project management role, 3 years of which are in a drug safety and pharmacovigilance role. Candidates with less than 5 years of experience will be considered if he/she has an advanced degree in a medical field
Understanding of the nature and work requirements associated with industry regulations related to this role
Ability to work independently with little supervision, self-motivation is a must
Operate with a sense of urgency and ability to continuously reprioritize
Ability to manage multiple activities simultaneously
High degree of attention to detail and organization
Ability to write concisely and cogently
Complete required documentation in an accurate and efficient manner
Follow-up in a timely manner
Ability to work with investigational site staff in a professional, productive fashion
Excellent interpersonal skills, work within a matrix environment and interact / communicate effectively across various levels within the organization when needed

Associate Director, Drug Safety Resume Examples & Samples

Manage the SABR global audit and inspection readiness program, including
5+ years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences
Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations
Direct experience in GVP compliant quality systems
Regulatory affairs, quality assurance or clinical departments experience is preferred

Executive Director, Drug Safety Resume Examples & Samples

Provide support and back-up for VP of Pharmacovigilance and tactical support to the Safety Oversight Committee
Offer medical judgment on complex safety issues
Determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor
Present safety data to DSMBs for assigned products
Liaison with partner company’s drug safety team and clinicians and provision regular safety summaries
Provide vendor oversight for assigned products
Participate in cross-functional project teams; communicates across organizational levels and functions
Provide medical review of case narratives for medical content and accuracy
Participate in SOP updates, audits, data analysis and other ad hoc activities
Write/update core safety information for assigned projects
Write the safety sections of regulatory documents for assigned projects (i.e. protocols, IBs, IND submissions, annual reports etc.)
Prepare and/or review safety documents in response to regulatory inquiries
Support the medical coding group on an ad hoc basis
Guide and/or train external personnel/parties involved in Isis’ clinical studies
Provide clinical education support for internal company customers
Maintain clinical and technical expertise in the therapeutic areas in which Isis operates (i.e. through review of scientific journals, attend scientific and key technical meetings etc.)
Assist in accomplishing department and corporate objectives
May be required to act as medical monitor for some clinical trials

Post-doctoral Pharmd Fellow Oncology Drug Safety Resume Examples & Samples

Contribute to Pharmacovigilance and Risk Management planning for designated products
Track and evaluate potential safety issues
Perform Project Management activities for multiple studies in a program
Support the SERM lead in the development and/or execution of RMP or REMS risk mitigation activities
Conduct/support signal detection and evaluation according to SOPs and guidelines
Prepare Safety Evaluation Reports as necessary for safety signals or other issues (product quality)
Provide safety content review of clinical protocols, study reports, informed consent forms, and Investigator Brochures for designated products
Support the SERM Lead in responding to safety requests for assigned product(s) from Regulatory Authorities, Affiliates and other internal functions
Attend weekly SERM meeting to relay safety concerns raised in Study Team/Clinical Sub Team Meetings
PharmD degree
Good medical and scientific judgement, attention to detail and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally

Drug Safety Manager Resume Examples & Samples

The implementation of continuous process improvements, delivering efficiency to global projects
Understanding of pharmacovigilance and safety reporting requirements globally
Responsible for all aspects of collection, processing and reporting of Serious Adverse Events (SAEs), adhering to all data protection guidelines, Health Insurance Portability and
Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures
Line management responsibility for the Regulatory Submissions team
Participates in process development, budget reviews, and project management
Manages projects to include responsibility for study budgets and expenses; customer invoicing; provision of project updates and reports to sponsors
Reviews, advises, and approves drug safety portions of project proposals
Reviews and approves clinical safety sections of study protocols and Case Report Forms (CRFs)

Associate Director, Drug Safety Resume Examples & Samples

Oversee the proper and timely collection and reporting of AE information from all sources
Prepare and manage of all safety reports (eg. IND safety reports, DSURs, PSURs, Annual reports, etc.)
Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed
Review of protocols, case report forms, guidelines, CSRs and manuscripts as requested
Identify, select, implement and manage the company’s safety database(s)
Oversee and supervise the work of drug safety agencies and independent contractors
Develop and maintain pharmacovigilance related SOPs, policies and work instructions
Create and track case processing metrics for internal monthly safety reports
Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities
Collaborate with clinical, biostatistics, data management, clinical operations and regulatory with respect to safety related issues
Serve as the pharmacovigilance subject matter expert
Maintain current knowledge of regulatory and industry standards
Maintain knowledge of pertinent MedDRA SMQs/CMQs

Senior IT Project Mgr, Drug Safety Systems Resume Examples & Samples

Bringing hosted and SAAS systems under the LCS/GRA Tech Governance process for all upgrade, enhancement and customization work
Identifying compliance and operational gaps as well as creating and implmenting a clear plan to close those gaps
Centralize management of hosted systems and associated vendors
Develop work instructions, processes, verification forms and SOPs where gaps exists
Ensure SLAs are in place for each vendor
Establish a vendor governance structure
Centralize system and configuration support
BS degree strongly preferred
PMP certification a plus!
5 years of IT Project Management

Specialist, Drug Safety Resume Examples & Samples

The Drug Safety Specialist is a regional role based in Summit, NJ
Reports (at a minimum) to Associate Director, Case Management
Responsible for
Minimum of B.S. or the equivalent combination of relevant education or professional experience
Current registered medical license preferred
Four (4) years pharmaceutical/biotechnology industry experience
Process management experience
Clinical knowledge of therapeutic areas, patient populations, and drug classes
Proficiency in technical safety systems including Celgene’s current central safety database and medical coding
Understanding of global regulatory requirements for pharmacovigilance
Computer and database skills

Regional Drug Safety Lead-spain Resume Examples & Samples

Maintain knowledge of local pharmacovigilance regulations with particular reference to any deviations from standard ICH / EU definitions and requirements and communicate accordingly
Support the contact point for local pharmacovigilance matters, dealing with queries made via telephone, e-mail or face-to-face concerning general pharmacovigilance issues
Receive, acknowledge and assess post-marketing and investigational safety reports for entry into the drug safety database and request additional information where appropriate
Quality control post-marketing safety reports, including case narratives
Assist Operations colleagues with submission of expedited reports to Health Authorities as required. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of pharmacovigilance agreements with business partners
Liaise with Quality Assurance colleagues as appropriate for local quality complaints
Under the direction of the Quality Standards and Training group, and the Head of South EMEA, support the development of local quality management and the preparation of local SOPs/job aids (JBAs), ensuring integration with GDS procedures
Assist GDS scientists / managers and physicians by collating relevant local information in support of their roles (i.e. data for aggregate report preparation, signal detection)
Liaise with GDS physicians and scientists / managers to ensure that pharmacovigilance processes are adequately addressed and reflected in protocols/supporting documentation for local initiatives where safety data may be directly or indirectly collected. Collaborate with Clinical Development and Medical Affairs as appropriate
Collaborate with GDS Licensing & Safety Agreement colleagues, to advise local stakeholders on the inclusion of Pharmacovigilance language in local contracts with third parties
Collaborate with GDS Risk Management in the implementation of local risk management planning strategies
Track product lists and requirements for periodic reporting for local products
Assist with audit preparation
Support GDS at the local level through membership of the Country R&D Council (CRDC) ensuring interaction and communication across country R&D functions, contributing to compliance and inspection readiness and working with local Medical Directors to ensure two-way communication with Commercial colleagues with aligned objectives
Support GDS as contact for pharmacovigilance on local project teams
Supply information to GDS physicians to allow preparation of regulatory responses to specific safety concerns with local marketed or investigational products
Collaborate with GDS physicians in making recommendations for local labeling changes, and in developing required regulatory documentation
Communicate all potential issues to Senior Managers and the EU Qualified Person for Pharmacovigilance as appropriate
Pharmacy qualification or other healthcare related degree (fulfilling requirements for a ‘Local Contact / Responsible Person’ where applicable) is required
Generally has at least 2 years of drug safety experience in a pharmaceutical company with demonstrable writing skills
Post-graduate qualification is desirable

Risk Management Lead, Global Drug Safety Resume Examples & Samples

Summarize safety data from investigational and marketed use
Authoring RMP’s, REMS to meet regulatory and internal deadlines
Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and f facilitate document review by other contributors
Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
Manage portfolio of products/projects related to risk management
Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off
Assist in the management of Risk Management project timelines
Represent Risk Management on cross functional teams
Interface with other Shire functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates
Participate in other teams and committees as assigned

Senior.director, Drug Safety Physician Resume Examples & Samples

Review, analyze, and compile safety data, and present the results
Contribute to the generation of aggregate safety reports including periodic/development safety update reports, periodic benefit risk evaluation reports, and provide medical input for review of new or existing safety documents that ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
Support of the internal PV Operations (case processing) function
Service as a medical resource for the generation and review of clinical trial protocols, and investigator brochures
Provide medical safety input into the development of Reference Safety Information
Provide medical safety and Pharmacovigilance (PVG) expertise in-house and by consultation with outside vendors for all development programs
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Contribute to safety and pharmacovigilance training programs
Provide safety training at investigator meetings
Collaborate with Regulatory Affairs to ensure appropriate reporting of PVG and drug safety information to regulatory agencies and prescriber community
Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services
6+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
Experience with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event summary statements
Experience with data entry, MedDRA or similar coding and safety database systems

Drug Safety Compliance Lead, Jpac Resume Examples & Samples

Bachelor’s degree in a scientific discipline or related field, preferably Health Care Professional
Good communication, presentation, and interpersonal skills
Good collaboration and negotiation skills
Excellent problem solving skills and attention to detail
Demonstrate a can-do attitude
Good understanding of international drug safety regulations
Strong work ethic and the capacity to work in a fast-paced environment; flexible and quickly adaptable to changing priorities
Experience with both investigational and marketed products
Experience in Drug safety regulations and operations in Japan highly preferred

Drug Safety Operations Specialist Resume Examples & Samples

Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of primary review
Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data
Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes
Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate
Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues
May liaise with client in relation to details on day to day process of cases
Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure
Ensure compliance to Quintiles high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables
Executes administrative operational tasks as required e.g. committee and laboratory management
Collaborate with SO and LSM to help achieve operational departmental goals i.e. understands metrics appropriate to quality document management and assist in the achievement of productivity utilization and realization metrics
Working knowledge of Lifecycle Safety services. Familiarity with functionality of the Quintiles Regulatory Database and Endpoint Tracking Database
Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs
Sound organization and time management skills
Good attention to detail and accuracy and maintain high quality standards
Demonstrate good IT skills
Effective written and verbal communication skills
Fluent Japanese(reading and writing) as well as business level English(reading and writing)
High School Diploma with 5 years' relevant experience or Bachelor's Degree in scientific or healthcare discipline or equivalent combination of education, training and experience

Senior Associate, Drug Safety Resume Examples & Samples

Triage of all incoming initial and follow-up PML reports in RDC system
Evaluation of the existing clinical data points and generation of relevant follow-up queries for all reports of AESI using, clinical knowledge, Pharmacovigilance experience, and communication skills
Collaboration with affiliate/distributor/and associated external AE collection partners for follow up queries in ROW locations
Direct administration of queries with healthcare providers in the US; additionally for US reports - provide established Biogen resources as needed
Collaboration with US Biogen field staff (MSLs, ABMs) to gather relevant clinical data
3+ years in a clinical setting (preferred but not required) - 2+ years in Drug Safety department in pharmaceutical/biopharmaceutical industry

Drug Safety Therapeutic Resume Examples & Samples

Has an advanced degree in health or life sciences (e.g., Ph.D., M.D., D.V.M.) with a minimum of 10 years of significant industry and/or academic and managerial experience
Is highly knowledgeable and experienced in all aspects of liver disease drug discovery, through to POC
Has excellent written and verbal communication skills in English
Has experience of working through virtual and/or matrix team models in basic research
Capable of leading a matrixed team comprised of scientists from within Takeda as well as external collaborators
Has significant experience of participation in diligence activities in the preclinical discovery function
Proven project management expertise is desirable

Drug Safety / PV Senior Scientist Resume Examples & Samples

Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role
Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills
Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff
Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts

Senior Consultant, Epidemiology & Drug Safety Resume Examples & Samples

Assist with design and implementation of epidemiology, pharmacoepidemiology, and drug safety studies and other related research projects. Senior consultants may serve as the lead
Contribute to the development of high quality proposals for new projects
Knowledge of epidemiology methods and concepts, ideally with a masters or doctorate degree in epidemiology, health services research or relevant related discipline
Work experience in related area such as pharmacoepidemiology, epidemiology, or health services research, ideally with at least 2-3 years (4-5 years for Senior Consultant) experience in applied health research or consulting environment
Strong interpersonal and communication skills and ability to work collaboratively in a team environment on multiple priorities and projects simultaneously
Strong project management skills, organizational skills, and ability to prioritize competing tasks

Senior Director, Drug Safety Operations Resume Examples & Samples

Processing of all adverse events in Argus for investigational and post-marketed products
Submissions of expedited reports to the FDA & other health authorities
Developing standard procedures and guidelines for US Drug Safety operations, which are integrated and fully aligned across all GDS sites
Developing cross-functional Pharmacovigilance procedures & ensure proper reconciliation with other systems processing safety information
Effectively utilizing case metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives
Proactively leading case processing/ case quality improvement initiative
Fully supporting training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc., in collaboration with US Drug Safety Quality System Compliance and Training group
Negotiating agreements and processes with business partners
Vendor oversight and management for all outsourced or insourced US Drug Safety operational activities
Plays a leading role in all activities to ensure readiness & proper management of FDA inspections
Supports US safety physicians in the preparation of Periodic reports (e.g. PBRER, PADER, DSUR) & other safety documents as required
Developing efficient workflows in Argus in conjunction with Global Drug Safety Systems and Global Drug Safety Operations team
Representing drug safety on project teams, other departments, and committees as needed
MD, PharmD or Nursing PhD with 12 years relevant experience of which eight years are in pharmaceutical drug safety, with drug safety operations managerial experience at least 5 years; equivalent combination of advanced degree and less experience may be considered

Senior Drug Safety Case Manager Resume Examples & Samples

Applies judgment and professional drug safety expertise. Performs highly technical work including the following. Other duties may be assigned
Performs accurate data entry based on source documents and the uniform and timely processing of adverse event reports including writing meaningful case narratives
Extracts pertinent information from patient medical records and literature
Performs triage assessment of adverse event information
Performs quality control of adverse experience information processed in the safety database and confirms expedited reporting to health authorities
Creates simple queries using the safety database. Acts as a liaison with internal and externalbusiness partners on Safety operation management issues
Tracks adverse event information and prepares administrative reports for management
Participates in the creation and compliance of Actelion policies and department standard operating procedures
Assists in the preparation of internal and external reports including metric reports and aggregate reports per US and international regulations
Create and generate safety information for internal use, and safety review boards
Contribute to inspection readiness planning, as needed
Participate in validation of safety database upgrades, as needed
Participates in the review of the safety section of protocols, support
CRF development, assists in writing Safety Data Management Plans and performs clinical trial database reconciliation
Mentors internal sources and participates in Safety Operations training initiatives
Interact with Clinical team and other Actelion Drug Safety units in the review, processing, and reporting of safety information
Bachelor’s degree (or comparable non-US Degree) in Pharmacy, Nursing or related health field
Five years’ experience in Drug Safety
General knowledge of coding thesauri and drug dictionaries

Senior Drug Safety Case Manager Resume Examples & Samples

Takes a proactive role identifying and communicating opportunities for improvement, identify issues, conducting root cause analysis and proposing solutions. Provides input and strategic direction to management on any related case processing activities associated with her/his assigned role
Plays the role of mentor to others, lead process improvements. Takes responsibility overseen one or more specific case processing activities. This person supports people's development and technical skills
Performs complex medical assessments of adverse event information according to SOP and working instructions
Capable of performing active follow-up via telephone contact, is able to discuss cases with HCPs, identify and ask for critical and relevant information
Supports improvements on the quality of all adverse event information with emphasis on serious and events of interest reports that require expedited reporting to authorities
Assists managers on monitoring case priorities and timely reportability of adverse event cases to health authorities and corporate partners
Serves as a PV expert providing safety expertise to other functions such as Medical affairs, clinical teams. Supports clinical trial safety activities related to study initiation, reconciliation, and may assist Drug Safety Physician in preparing Safety Data Management reports
Contributes to inspection readiness planning. May participate as a matter expert during regulatory audit interviews
Support GDSS initiatives including the identification of new applications, user requirement and enhancements, validation testing
Collaborates with the compliance group in Safety Operations training Processes
Contributes providing feedback on team performance assessment review
Minimum of four years’ experience in Drug Safety data management, proficient in case processing and review of safety data
Three or more years of post-graduate clinical experience in hospital or clinical practice settings is an advantage
General knowledge of medical terminology, MedDRA coding and drug dictionaries
Excellent knowledge of FDA and international adverse event reporting regulations per International Conference of Harmonization (ICH) Guidelines and the ability to interpret and apply applicable regulation to resolve issues
Experience using drug safety database (e.g. ARIS G or Argus)
Computer proficiency and computer data entry experience (Word, Excel, and Power point)
Critical and strategic thinking
Excellent organizational skills and the ability to work under pressure and meet tight timelines
Effective verbal and written communication
Strong interpersonal skills. Able to interact with other people both individually and in groups
Ability to work with others to identify, define and solve problems; explore options to make good decisions

Medical Science Director, Drug Safety Resume Examples & Samples

Takes a leadership role, in collaboration with other members of the USDS Governance Committee, in the creation of the organizational strategy, goals, and objectives for the department
Functions as the affiliate Risk Management Plan Implementation Coordinator and US Periodic Adverse Drug Experiences Report (PADER) reviewer
Manages USDS Data Analyst
Develops relationships and serves as a Drug Safety leadership resource across Genentech and Roche stakeholder groups including US Medical Affairs, US Commercial Organization, and Global Safety Science. This includes serving on or leading US and Global working groups and committees
Serves as the US Drug Safety Lead to the U.S. Medical Affairs (USMA) Medical Teams, oversees the integration of the Clinical Safety Associates role into USMA therapeutically aligned medical teams, leads or delegates the USDS representation to the Medical Affairs Review Committee (MARC) for the therapeutically aligned medical units
Serves (possibly as a Lead) on US Medical Affairs Workstreams and projects as required
Leads the innovation, development and implementation of USDS data generation and analysis activities
Assists in the rollout of new safety initiatives and implementation of new Health Authority safety requirements
Through coordination with the USDS Compliance and Training Group provides appropriate representation during safety-related regulatory inspections or internal quality assurance/corporate compliance audits
Address queries by the Clinical Safety Associates or medical teams on safety-related content for US Medical Affairs sponsored study protocols and
Provide advice as required to address queries involving safety reporting for investigator-supported studies when additional higher-level input is required
Providing research and clinical expertise to Clinical Safety Associates/Drug Safety Associates as necessary
May participate in the preparation of abstracts, posters and presentations for scientific meetings and congresses based upon collaborative research initiatives

Senior Specialist, Drug Safety Resume Examples & Samples

Candidate is required to have three years of safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory
Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible in order to meet daily competing priorities of the business
Candidate should be extremely organized with strong documentation and analytic skills
Demonstrates leadership, and excellent communication and interpersonal skills
Ability to project manage and independently drive projects to completion
Strong knowledge of and experience with advanced MS Excel and Access

Drug Safety Coordinator Resume Examples & Samples

High School graduate is required; Bachelor’s Degree preferred
Drug safety experience is desired
Proficient with MS Office is required
Data entry experience is preferred
Understanding of medical terminology and ability to summarize medical information is preferredDrug & Product Safety Operations

Drug Safety & PVG Manager Resume Examples & Samples

Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives
Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with Associate Director/Director/VP
Works with Business Development to actively solicit new business, as needed
Reviews, advises, and approves drug safety portions of project proposals to ensure wording adequately reflects the scope of work for drug safety. Reviews and approves clinical safety sections of study protocols and Case Report Forms (CRFs). Approves budget projections for the project

Manager, Drug Safety Services Resume Examples & Samples

Industry experience of which 4 years is relevant to phannacovigilance/drug safety knowledge
Good verbal, written and presentation skills
Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level
Work collaboratively with PV&DSS Management's team
Leadership capabilities
Good Communication
Ensure client and global regulatory compliance
Will present and share useful business information across depat1ments and functions
Anticipate/identify problems and takes appropriate action to conect
Knowledge of medical and drug terminology
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Knowledge of worldwide regulatory requirements and reporting of adverse event for both

Senior Drug Safety & Risk Management Specialist Resume Examples & Samples

Life science/Pharmacy degree or Registered Nurse
Ability to lead projects under the supervision of the UK and Ireland Head of Drug Safety and Risk Management
Ability to follow standard operating procedures
Be able to work independently and as part of a team
Strong identification with Celgene’s values
Demonstrable relevant experience within a Pharmaceutical company or CRO
MONEU
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Associate Manager, Drug Safety Resume Examples & Samples

Strong relationship-building and interpersonal skills
Good ability to assess staff performance and propose effective strategies to enhance existing strengths and fill any noted skill or knowledge gaps
Good ability to propose solutions to effectively address any performance issues
Ability to provide mentorship and guidance to project support staff
Ability to grow and develop project support staff through multiple levels within the department career ladder
Ability to coach project support staff in development of technical skills, efficiency and quality
Ability to work independently in a staff management capacity, in regular consultation with management
Ability to perform project review and process analysis, identify potential risks and process improvements – and propose appropriate action
Functions as a positive, engaging and motivating team player
Ability to direct, manage and coordinate the day-to-day efforts of multiple levels of staff
Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting
Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources
Good verbal, written and presentation skills
Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level
Work collaboratively with PV&DSS Management’s team
Leadership capabilities
Good Communication
Ensure client and global regulatory compliance
Will present and share useful business information across departments and functions
Anticipate/identify problems and takes appropriate action to correct
Knowledge of medical and drug terminology
Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
Knowledge of Medical Device Reporting desirable
Knowledge of aggregate reporting desirable
Financially intuitive
Knowledge of ICH guidelines
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance

Director, Risk Management / Drug Safety Resume Examples & Samples

With oversight from Head of RM, responsible for all risk management activities for assigned compounds including and not limited to: signal management; responses to regulatory agency queries; preparation, review and finalization of safety documents (DSURs, PSURs, development RMPs, RMPs, etc., review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.) focusing input on safety sections
Proactively identify and develop plans/strategies for non-compound specific risk management activities
May participate in medical review of individual cases to ensure adequacy or recording, summarization and handling of adverse events, including assessment of seriousness and expectedness safety sections
Actively participate in process improvement activities within PVRM
Requires the ability to influence outcomes and change the thinking of, or gain acceptance of others in sensitive situations
Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify
Regularly interacts with Sr. Management or Executive levels on matters concerning specific compounds or problems
Medical Degree (board certification preferred): clinical experience and 7+ years industry experience in drug safety including significant experience with PSURs/ DSURs/(d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content) or

Principle Scientist, Drug Safety & Metabolism Resume Examples & Samples

Experience in conducting, monitoring, reviewing and/or summarizing residue chemistry, metabolism and bioanalytical studies to support domestic and international registration of pharmaceuticals
Experience in HPLC-UV/VIS/FL and LC-MS/MS method development and analysis as it pertains to residue chemistry and bioanalysis
Experience with Good Laboratory Practices (GLPs)
Knowledge of standard computer software applications for general office work (word processing, presentation, and spreadsheet)
Excellent verbal and written communication skills required, with good attention to details; Team player with strong inter-personal skills
Domestic and international travel required
Extensive knowledge of US-FDA, EU-CVMP and other regulatory agency scientific guidelines for conducting metabolism, pharmacokinetics, and residue chemistry studies of veterinary pharmaceuticals
Experience with conducting regulatory surveillance method trials required by US-FDA
Experience in pharmacokinetics and mammalian toxicology is also desired
Experience in managing junior level scientists is considered a plus, but not mandatory

Drug Safety & Pharmacovigilance Operations Manager Resume Examples & Samples

Participates in the daily management and execution of DS and PV operations
Monitors compliance with regulations, PV agreements and internal SOPs
Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned
Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans
Processes SAEs including case triage, data entry, coding review and narrative writing
Provides safety operations support for external submissions, signal detection and risk management planning activities
Participates in authoring of periodic safety reports (e.g., DSUR, PSUR)
Ensures compliant exchange of safety data between Akebia and its partners
Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices
Works with QA department to maintain a state of high PV inspection readiness across all regions/countries
Collaborates with contract service providers for case processing, aggregate reporting and quality management activities
Performance management of PV systems
Participates in regulatory inspections and company audits including MHRA/EMA PV inspections; prepares responses to audit findings that concern the DS and PV department
Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required
B.S. and minimum of 5 years experience in drug safety/pharmacovigilance in a pharmaceutical setting
Masters degree and 3 years or relevant experience in drug safety/pharmacovigilance in a pharmaceutical setting
Global pharmacovigilance operations experience with products in development
Safety database, MedDRA coding and data entry experience
Knowledge of FDA and EU legislation and ICH Efficacy guidelines
Strong analytical and problem solving skills with superb attention to detail
Strong verbal, written technical communication and presentation skills
Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
Proven ability to work within a cross-functional, matrixed team

Director, Pharmacovigilance & Drug Safety Resume Examples & Samples

Oversees day-to-day activities of drug safety and medical information staff; works closely with team members to ensure timely and accurate reporting of critical information
Develops Standard Operating Procedures (SOPs) for drug safety surveillance, adverse event, drug coding, and medical information
Develops signal detection, literature review, trend analysis, and risk evaluation and mitigation strategies
Investigates, evaluates and conducts medical review of adverse event reports associated with investigational and marketed drugs
Prepares and reviews expedited safety reports for submission to the FDA
Prepares and reviews periodic adverse drug experience reports (PADER) and Periodic Benefit-Risk Evaluation Report (PBRER) for submission to the FDA
Acts as liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Assists in the selection and hiring of drug safety and medical information personnel. Evaluates employee performance
Other duties related to pharmacovigilance, drug safety and medical information as assigned
Five to seven years’ experience in pre-marketing and post- marketing drug safety
Three to five years’ supervisory experience
Knowledge of FDA regulations and ICH guidances related to drug safety. Experience with Canadian and European Union requirements preferred
Ability to build and maintain good working relationships with clients, patients and healthcare professionals
Excellent oral and written communication skills, organizational and time management skills
Working knowledge of word-processing and drug safety/medical information database software
Must be sole U.S citizen with ability to pass a background investigation

Drug Safety Manager Resume Examples & Samples

Assist with maintenance of project budgets and oversight by identifying out of scopeactivities
Meetings, as requested
Manage small to midsize drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
Manage REG GRA projects in accordance with established timelines , budget, quality standards and/or contractual requirement
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Senior Manager, Safety Training, Drug Safety Resume Examples & Samples

A Master’s level degree (or Bachelor’s Degree with relevant experience) in medical or life sciences, or a combination of relevant education or professional experience
Six years’ experience in Drug Safety/Pharmacovigilance to include work with either a European or Global remit
Expert knowledge of Pharmacovigilance Legislation including risk management
Broad command of GVP requirements
Specific experience and understanding of quality issues and requirements in relation to Pharmacovigilance and risk management/ability to understand the implication of lack of compliance or regulated processes
Training methodologies, assessment and evaluation of training effectiveness
Proficiency in technical safety systems including ARISg

Senior Drug Safety Manager Resume Examples & Samples

Oversee the process for scheduling, planning, managing, and authoring aggregate safety reports for all Biogen investigational and marketed products; including PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans
In order to ensure a seamless transition from signal management to aggregate report writing, the Senior PV Scientist will collaborate with the product lead PV Scientist to understand the product’s risk profile, safety and benefit risk considerations, evaluated signals, and events of interest
The Senior PV Scientist will provide oversight to any contracted vendors involved in the preparation (e.g., document management and authoring) of assigned aggregate safety reports. The Senior PV Scientist will have oversight for the quality of all assigned aggregate reports including those prepared internally or through contracted vendors
Senior PV Scientist serves as the subject matter expert on aggregate safety reporting requirements, practices and documentation for the PV Scientist group, SABR and other cross-functional collaborators. This includes PSUR, DSUR and RMP requirements
In collaboration with PV Scientist team, lead initiatives for process improvement and efficiencies and represent PV Scientists in cross-SABR discussions regarding processes, databases, etc. Contributing to SOPs, job aids and templates aggregate reports
Serves as leader and expert for SABR regarding Global RMPs, including current regulations, tracking, content and strategy
Mentoring junior PV Scientists and helping to train new PV Scientist staff members
Ability to lead and the aggregate safety reporting and risk management initiatives for a given product, including: setting strategy for PV activities for the product specifically around aggregate safety reports and risk management plans; proactively identifying and solving problems; communicating with Senior Management regarding product updates and safety; and mentoring other PV Scientists on the product team
Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology)
Able to interact collaboratively and effectively in a team environment (including Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Ability to oversee vendor responsible for outsourced activities, and to provide project management skills to ensure deliverables from internal and external contributors are completed on time with high quality
Able to develop and conduct, independently and/or collaboratively, all aspects of aggregate safety reports, risk management plans and responses to associated regulatory agency requests
Able to apply clinical judgment to interpret case information and help lead the product team in decision making

Drug Safety Physician Resume Examples & Samples

Perform medical review of individual safety reports
Participate in joint team safety reviews with external partner (s)
Participate in joint labeling team discussions
Participate in internal program safety team reviews
Lecture/train internal staff on pertinent safety issues to improve the query process for capture of safety data
Collaborate with the Risk Management group to support risk management strategies
Review all routine and ad-hoc aggregate safety data analysis for clinical relevance
Contribute to development/updates of documents such as Investigator’s Brochure, Informed Consent Document, Annual Safety Reports, periodic reports, integrated safety summary, US IND updates and clinical protocols
May develop responses to regulatory queries
May provide 24/7 medical coverage, if necessary
MD (board certified preferred or ex-US equivalent)
At least 2-5 years pharmaceutical industry experience in one or more of the following areas: Drug Safety or Risk Management in a global setting preferred
Excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required)
Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
Prior experience with business partner a plus

Drug Safety & Risk Management Senior Specialist Resume Examples & Samples

Contribute as subject matter expert for Affiliate Drug Safety and RM related issues when applicable
Contribute to the GDSRM Ambassadorial role within the Affiliate as a drug safety member
Contribute to effective working partnerships in collaboration with key Affiliate Stakeholders, GDSRM, GDSRM EMEA/APAC and EU QPPV in support of Celgene’s Pharmacovigilance (Drug Safety and Risk Management) System
Contribute to GDSRM continuous process improvement and leverage of innovation to drive technical and operational excellence in support of higher order Drug Safety and Risk Management throughout Celgene’s GDSRM Network
Scientific/Pharmacy degree or equivalent
2+ years Pharmacovigilance experience or equivalent (as applicable concerning level of the role)
Excellent knowledge of applicable national Pharmacovigilance legislation
Broad appreciation of global regulatory requirements for Pharmacovigilance
Proficiency in technical safety systems including IRT, OST and ARISg
Good written and verbal communication skills
Good analytical and diagnostic skills
Ability to demonstrate pro-activity
Work independently and as part of a team
Fluent English and Hungarian is mandatory

Senior Director, Drug Safety Resume Examples & Samples

FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
Provide strategic drug safety direction to Clinical Operations and CROs to execute the programs (review safety monitoring plans, ICF safety language, etc.)
Provide guidance and review safety section(s) of protocols, informed consent forms, statistical analysis plans, and clinical study reports
Represent the medical (clinical) function on one or more clinical study teams
Support new IND filing activities
Represent the Drug Safety department in DSC, SET and similar governance meetings
Provide strategic guidance and direction for the development, enhancement, and implementation of global safety systems initiatives to ensure regulatory compliance for AEs reporting and analysis
Provide strategic guidance on the planning and preparation of the adverse events section of protocols for FivePrime clinical studies
Allocate, administer, and direct resources within department to ensure all safety reports are processed and reported according to industry guidelines and external requirements
Oversee and establish appropriate metrics to ensure proper quality and timeliness of all safety management activities
Provide guidance on regulations and their impact on Safety management processes and procedures
Ensure that all safety reports received from clinical source are processed and reported according to ICH-GCP guidelines, regulatory requirements and our SOPs
Perform quality control review of all cases to ensure accuracy, integrity and completeness of information entered in the CRO safety database
Provide ongoing evaluation and guidance to ensure that our safety handling processes are efficient and scalable for future company growth
Monitor industry’s best practices and changes in global safety regulations
Other projects when assigned
M.D. highly preferred, will consider strong candidates with alternate medical experiences. Specialization and/or experience in oncology or hematology preferred
Minimum of 15+ years industry experience or equivalent experience in the management and execution of phase I-III trials
Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environment
Extensive knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry
Expertise in MedDRA dictionary with relevance to adverse event coding
Experience in working with software based drug safety systems, preferably the ARISg safety database (or AERS, Argus, etc.)
Expert knowledge of domestic and international safety regulations, Good Clinical Practices, principles of drug development and safety assessment of marketed and investigational drugs
Excellent clinical judgment and ability to articulate complex clinical issues in a scientifically sound and understandable way
Ability to work effectively cross-functionally and in a highly collaborative environment

Global Drug Safety & Risk Management Resume Examples & Samples

Currently pursuing a Bachelor’s degree or the equivalent combination of relevant experience or professional experience
Proficiency in MS Word, Excel, and Outlook
Strong organizational skills, along with attention to detail and the ability to prioritize tasks

Specialist, Drug Safety Resume Examples & Samples

Performs data triage of source documentation and confirms valid individual case safety reports (ICSRs). Tracks the status of AE reports, performs electronic submissions and monitors metrics for compliance with ICSR reporting requirements to the global regulatory authorities
Manages business partner exchange of AE reports in accordance with safety data exchange agreements and performs reconciliation
Evaluates and identifies areas needing improvement or clarification and drafts procedural changes and adaptations as needed
Prepares periodic safety reports for the FDA including quality review of narrative summaries and quality assurance of the data prepared by the CRO
Minimum of 5 years clinical safety or pharmacovigilance experience required
Strong knowledge of safety monitoring and pharmacovigilance required
Experience in medical writing, strong interpersonal and communications skills, as well as organizational and problem-solving skills required
Ability to collaborate and interact with a wide range of health professionals and company personnel required
Knowledge of preparation of periodic safety reports required
Strong knowledge of FDA regulatory reporting requirements and GMP as well as GCP guidelines required
Strong interpersonal, communication and organizational skills required
Ability to analyze laboratory data and review source documentation of ICSRs required
Strong ability to construct narrative summaries of AE data from source documentation required
Knowledge of regulatory reporting requirements and formats for the FDA and international regulatory authorities required
Computer skills including knowledge of databases and querying databases for preparation of data analysis required
Experience with adverse event coding dictionaries (MedDRA) required

Drug Safety & Medical Information Officer Resume Examples & Samples

Provide and process medical safety information locally, to support all activities (local, regional and global) which have relevant safety aspects, and to maintains links and liaison with external and internal parties on Safety matters
Assume responsibility for educating and training relevant personnel in the affiliate
Creating and enhancing Pharmacovigilance (PV) awareness of Affiliate’s staff on global issues & follow-up on products
Contributing to the management of safety issues
Implementing and maintaining local safety processes
Bringing safety expertise and advice to other local functions when needed
Participating and/or providing Safety input in business and clinical activities (clinical programs, marketing & launch meetings, sales force conventions…)
Outlining and representing Roche corporate expertise and opinion towards local competent authorities
Register, monitor and respond to scientific questions of doctors, pharmacists or patients on all Roche products to provide the customer timely with accurate information
Review and approve the promotional materials with Roche medicines in accordance with the Belgian and Roche guidelines

Senior Drug Safety Case Manager Resume Examples & Samples

Applies judgment and professional drug safety expertise
Creates simple queries using the safety database. Acts as the liaison with internal and external business partners on Safety operation management issues
Participates in the creation and compliance of Actelion policies and department SOPs
Participates in the review of the safety section of protocols, supports CRF development, assists in writing Safety Data Management Plans and performs clinical trial database reconciliation
Mentors internal sources and participate in Safety Operations training initiatives
Minimum of five years related experience in Drug Safety
Excellent knowledge of FDA and familiarity with international adverse event reporting regulations per International Conference of Harmonization (ICH) Guidelines and the ability to interpret and apply applicable regulation to resolve issues
Excellent organizational and problem-solving skills, interpersonal skills, and the ability to work under pressure and meet tight timelines

Drug Safety Case Manager Resume Examples & Samples

Ensures accurate data entry and the timely processing of adverse event reports including writing meaningful clinical case narratives
Create queries for adverse event report clarification
Perform quality control of adverse event information processed in the safety database
Schedule expedited reports to health authorities to insure timely ICSR regulatory reporting requirement compliance
Track adverse event information and prepare administrative reports for management
Assist in developing and maintaining standard global procedures and guidelines for Drug Safety operations
Review, evaluate and assess adverse event information for regulatory reporting
Assist in the preparation of internal and external reports including metric reports and aggregate reports per US and international regulations
Interact with other Actelion Drug Safety Units in the review, processing, and reporting of safety information
Participate in/attend clinical team meetings when appropriate, provide technical advice and support to the clinical team
Represent Drug Safety Department in other company team meetings or conferences
Participates in Safety Operations training initiatives
Assists with special projects
Minimum of two years experience in Drug Safety case management
General knowledge of MedDRA coding and drug dictionaries
Detailed knowledge of FDA and familiarity with international regulatory safety reporting requirements
1-2 years post-graduate clinical experience in hospital or clinical practice setting
Knowledge of safety database systems
Excellent organizational and problem solving skills and interpersonal skills
Ability to work under pressure and meet tight timelines
Proficiency with word, Access and Excel software

Project Manager, Drug Safety Resume Examples & Samples

Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes/SOPS
Maintain quality review metrics and attend project quality meetings, as required
Maintenance of project budgets and oversight by identifying out of scope activities, change order management, etc
Manage all sizes of drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
Ensure audit readiness and/or PVSS representation at audits
Coordinate any committee activities as applicable under supervision
A minimum of 4 years of relevant clinical research / pharmaceutical industry experience, preferably with at least 2 years experience in pharmacovigilance / drug safety
This position will be required to be on site at the client’s site in Northern New Jersey
You will have working knowledge of MS Word, Excel and PowerPoint and possess the ability to multitask, remain composed and even-keeled in stressful situations, and perform effectively in spite of shifting priorities, workload and external pressures
Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other staff
Thorough knowledge of global safety processes and regulations
Good knowledge of medical terminology, coding systems, aggregate reports, regulatory submission understanding
Safety systems knowledge (ARIS-g, ARGUS, etc.)
Ability to work independently and lead teams
Fluent in written and verbal English

Drug Safety Manager Resume Examples & Samples

Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
Serve as a resource for investigational sites and ICON personnel on safety-related issues
Assist with generation of study specific procedures and with identifying out of scope activities in conjunction with the MSS Functional Lead
The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems

Drug Safety Data Coordinator Resume Examples & Samples

Ensures current conventions are followed when entering cases into the Safety database
Assists with obtaining follow-up safety data/information from study sites as appropriate
Assists with completion of necessary forms to set-up study specific databases/computer applications
Assists with preparing study-specific forms/templates
Attends project status meetings and reports status to management as needed
Escalates issues to management when needed

Associate Director, Drug Safety Services Resume Examples & Samples

Contribute to the generation and review of Time and Cost Estimates for Drug Safety Services business
Review safety costs for allocated projects, identify out-of-scope activities and work with the appropriate business units to process change orders
Provide appropriate and relevant PV&DSS input into project management, including risk analysis, control metrics and contingency planning
Liaise with medical, clinical, data management and regulatory personnel regarding safety issues, as appropriate
Support Business Development (BD) activities including client presentations and accurate input for costings and proposals
Ensure efficient, effective and economic operation of PV&DSS including management of quality, regulatory compliance, and adherence to project budgets
Review and approve Adverse Event Reporting Plans (AERPs), Reconciliation Plans, Randomization and Unblinding Plans, Endpoint Plans, Drug Safety Monitoring Board (DSMB) Charters, Post-marketing Surveillance Plans and any other client-specific safety plans ensuring optimal efficiency
At least 5 years line management or project management experience
Industry experience of which 6+years are relevant to drug safety knowledge
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products

Senior Associate, Drug Safety Resume Examples & Samples

Support the ICSR Processes & Submissions Associate Director with the implementation of the strategy and standards for Case Processing as well as the conventions for data handling
2+ years in a clinical setting (preferred but not required)
3+ years in Drug Safety department in pharmaceutical / biopharmaceutical industry
Proven ability to evaluate clinical data
Familiarity with GCP and Safety regulations
Able to effectively communicate orally and in writing
Able to produce clear, concise documentation
Able to interact collaboratively in a team environment
Ability to interpret regulations and apply the interpretation to departmental SOPs and guidelines

Drug Safety Case Processor Resume Examples & Samples

Case intake, duplicate check and registration of the case into the safety database
Case validation and triage
Data entry of Individual case safety reports into the safety database
Full data entry including medical coding and safety narrative
Responsible for medical coding (e.g. MedDRA, Company Product Dictionary, DRL code)
Review data entered in safety database for completeness and accuracy
Conduct Review and assessment of individual case safety reports obtained and route cases to approval via workflow
Perform causality assessment
Communicate and interact effectively
Follow up with sites regarding outstanding queries
Follow up on reconciliation of discrepancies
Handling case deletion if applicable
Perform other drug safety related activities as assigned

Drug Safety Physician Resume Examples & Samples

Responsible for assisting in Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department, preparation of risk minimisation measures and evaluation of effectiveness of same) within timely manner
Signal Detection :Medical review of signal reports including detection, evaluation and assessment
Prepare Medical Risk Assessments (MRAs) for various labelling, packaging and quality issues
Health Authority Responses:Assists in preparing or prepares responses to Regulatory Authority questions related to safety issues and conducts medical review
Responsible for providing medical comment/opinion on :Safety Information in labels, CCDS or RSI
Provides medical guidance to team members in medical aspects of drug safety and any other Mylan personnel
Writing & update of Standard Operating Procedures (SOP)
Assists or oversees any other project where SST is involved, as deemed necessary
Provides medical safety expertise and training to other personnel, as necessary
Keeps current with professional and pharmacovigilance regulations and knowledge
Liaise with global, regional and local Regulatory, quality, medical affairs, clinical research, commercial & PV Departments, affiliated companies and Mylan drug safety in performance of the above mentioned tasks
Assists in other Pharmacovigilance projects, as necessary
M.B.B.S/ MD/BDS from Recognized Instuitutes
Relevant experience of 1-5 years in organisations of repute
Experience in Clinical Trial as well as Post Approval Stages
Experience in Aggregate Reporting and Signal Management is a must
Proficiency in speaking, comprehending, reading and writing English is required / preferred

Mgr, Prog Mgmt, Drug Safety Programs Resume Examples & Samples

Consultative Partner Builder
Problem Anticipation and Mitigation
Project Plan Management
Contractual Obligations Management
Financial Management
Pharmacovigilance and/or adverse event Management
Professional Acumen
Comply with company and PMO standards and procedures
Responsible for managing Budget, Scope, Timelines and client satisfaction of complex compliance programs and services across all phases of the program
Develop professional, productive relationships with peers and subordinates that allows for the development of synergy, transparency and partnership within and between all departments delivering service to your client(s)
Be accountable for risk management strategies
Chair Program SLA reporting and updates within QuintilesIMS and with the client
Provide guidance to client’s based on their changing ecosystems by highlighting new innovations and updates that could help them be more efficient in their compliance approaches
Gather customer’s changing needs and perspectives, integrating those into product roadmaps
Manage change control and contract renewals for Nexxus Social program solutions
Pro-actively anticipate and solve project and program issues effectively
Oversee applicable project work streams and manage conflicts across those work streams
Begin to recognize and document areas of organizational improvement at QuintilesIMS and with customers working with other more senior team members
Own account finance process for revenue recognition, forecasting and invoicing/billing activities
4+ years of Program/Project Management experience
2+ years of drug safety expereince
Strong understanding of regulatory (FDA, EMA, MHRA) guidelines around the reporting of adverse events, PQC’s etc
Industry experience having worked in a safety role at a pharma company
PM Certification preferred
Demonstrated ability to set and achieve stretch goals quickly, while possessing strong people skills
4-year undergraduate or more advanced degree
Strong computer skills including Microsoft Project, PowerPoint and Excel (functions and formulas)
Self-starter with drive to develop good collaboration skills
Good organization, presentation and customer service skills

Drug Safety Manager Resume Examples & Samples

Attend bid defence meetings, as requested
Perform other activities as identified and requested by managementManage MSS projects in accordance with established timelines, budget, quality standards and/or contractual requirements
Provide project and/or line management of assigned Drug Safety and Administrative staff
Serve as a mentor and role model for Drug Safety staff
A minimum of 4 years of relevant clinical research / pharmaceutical industry experience, preferably with at least 2 years’ experience in pharmacovigilance / drug safety
Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
Demonstration of professional demeanor, judgment and discernment in interactions with clients, colleagues, and other staff
Very good computer skills
Very good presentation skills
Very good ability to mentor staff
Ability to self-start and show initiative

Operations Spec Assoc Mgr-drug Safety Resume Examples & Samples

 Co-ordinate implementation of service operational initiatives; system requirements; client requests and electronic reporting
 Demonstrate a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow
 Provide historical perspective and input on operational processes in collaboration with Lifecycle Safety Management (LSM)
 Provide leadership to teams working in a matrix environment and mentoring and coaching to junior staff
 Promote sharing of ideas within teams to improve process efficiencies. Follow through effectively on actioned implementations
 Ensure team is following standard best-in-class practices established by Lifecycle Safety Infrastructure
 Establish ongoing and effective service operations communications with LSM to ensure SO is providing high quality deliverables and meeting client expectations and to discuss general project status, milestones, SOW, project issues etc
 Ensure financial project performance through oversight of key performance metrics (revenue, direct costs, time-sheet costs, utilization, and realization
 Works with LSM constructively in a matrix framework to achieve project and customer deliverables; proactivity identifying issues and proposing solutions, providing them with technical support, reports, metrics, statuses, identifying SOW changes and potential change orders, delegating client requests and implementation of new initiatives
 Establish and maintain effective service operations communications and provide regular feedback to operations team manager; clinical project manager; customer delivery manager (LSM) on project metrics, out of scope work challenges/issues and successes
 Ensure that a positive, collaborative team environment with project team members is maintained, encourage, motivate and lead by example, provide training and mentoring for project team members and operations staff, oversee allocation of team and project resource
 Work with Lifecycle Safety LSM constructively in a matrix framework to achieve project and customer deliverables
 Assist in the implementation of process initiatives; provide corresponding metrics to illustrate the productivity/profitability of new initiatives. Communicate confidently to the logistics and practicality of new processes
 Collaborate with operational team and managers to resolve issues relating to employee performance, efficiency and morale
 Ensure staff are trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs), FDA and ICH guidelines and regulations, Working Instructions and project instructions
 Implement and support service operational decisions as determined and instructed by senior management
 Participate in training across Lifecycle Safety service offerings. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies
 Lead team to achieving departmental goals e.g. utilization and realization productivity metrics
 In-dept knowledge of Lifecycle Safety processes audit practices, governing safety legislation/regulation; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills
 In-dept knowledge knowledge and understanding of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles SOPs
 Strong organizational skills and attention to quality compliance
 Mentoring and coaching skills
 Strong project management and leadership skills
 Strong presentation and customer focused skills
 Effective judgment, decision-making and problem solving skills
 Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives
 Demonstrate strong cooperative relationship with team and LSM
 Excellent written and verbal communication skills, effective report writing skills
 Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities

Drug Safety Physician / Medical Director Resume Examples & Samples

Knowledge of industry regulations and drug safety practices globally
Knowledge of adverse event case report triage processing
Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.)
Strong skills in presenting drug safety topics for regulatory authorities or at conventions, meetings, etc
M.D. degree and board certification/eligibility in a specialty appropriate to the products of the division are required
5 years of experience post-residency, with at least 3 years of experience in pharmaceutical/biotechnology company
Exposure to working relationship with FDA, EMA, or other regulatory authorities is preferred
Knowledge and understanding of national and international regulatory guidelines are a plus
Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice

Senior Associate, Drug Safety Resume Examples & Samples

Executes and monitors compliance through various monitoring reports and other oversight activities and ensures the implementation of effective Corrective and Preventative Action plans,
Acts as subject matter expert on operations and oversight of AE case processing partners during audits/inspections as necessary
Works with the Case Processing Oversight Associate Director to develop / review governing documents, such as SOPs, Safety Management Plans, and Safety Data Exchange Agreements, as necessary
Support the following partner / vendor oversight activities in relation to Case Processing

Drug Safety Review Specialist Resume Examples & Samples

May perform initial triage of source documents for duplicate check within the Global Safety Database, case priority, Awareness Date, and closure/submission timeline
Review source documents for accuracy of triage assessment to include case priority, Awareness Date and internal and external completion/submission dates
Perform initial safety review of adverse events to determine seriousness, expectedness, reporter’s causality, and overall event resolution
Ensure that the correct suspect drug was selected within the Global Safety Database
May write Pharmacovigilance (PV) comment for non-serious cases with guidance from Medical Reviewers
Using expertise in therapeutic area, ensure that data has been entered and coded correctly by data coordinators and medical reviewers
Request case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters in conjunction with local affiliates
Create and issue regulatory reports, including individual case safety reports using the Submission Criteria
May also include distribution/submission to affiliates or Regulatory Authorities of ICSRs, as appropriate
Take initiative to recognize, prioritize and escalate potential safety/ compliance issues
May participate in risk assessments and signal detection activities for therapeutically aligned products
Interact with other GPV functional areas to process adverse events efficiently and reliably
Perform case cleanup as required for preparation of aggregate Reports
May participate in literature review activities related to adverse event reporting with oversight from Literature Team reviewers
Perform Source Verification quality checks as requested/necessary
Serve on departmental committees and projects as needed To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required

Drug Safety Case Manager Resume Examples & Samples

Contribute to safety database processing and coding conventions manual
Data migration and cleaning activities
Contribute to GDS projects and process improvement initiatives as required
University degree in life sciences (e.g., pharmacy, nursing) or equivalent education in health related field
At least 2-3 years experience in safety data processing
Knowledge of medical terminology, coding thesauri and medical/drug dictionaries, and general understanding of disease processes
Excellent organizational and problem solving skills, interpersonal skills, and the ability to work under pressure and meet short timelines
Fluency in English, both verbal and written

Drug Safety Quality Specialist Resume Examples & Samples

Demonstrated knowledge of domestic and international regulatory safety reporting requirements
Must have excellent organizational skills and attention to detail
Must be able to work at program level with multiple studies or on multiple programs
Strong communications skills (verbal and written)
A BA/BS or equivalent training with minimum 2 years of experience in a Drug Safety department
Normally receives none or general instruction on routine work and may need detailed instruction on new assignment
May manage junior administrative staff
Ability to sit and type on computer keyboard for long periods of time

Drug Safety Public Health Specialist Resume Examples & Samples

AA or BS degree (or equivalent experience) and little to no experience
Industry experience in the health, clinical, bio-pharmaceutical, or relevant industries such as, pharmacy technician, nursing assistant is valuable but not required
Sets work priorities and direction with input from senior staff/Manager
Transferring electronic files to Department’s Shared drive
Renaming files to specified naming conventions
Reconciling files to ensure that all the documents are present
Recognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal resources
Excellent computer skills in Microsoft environment (Microsoft Excel, Power point, Word and Excel)
A quality driven individual with strong attention to detail and accuracy is required
Basic understanding of medical and drug terminology preferred
Demonstrates success working both independently and in collaboration with others
A demonstrated ability to manage workload, prioritize, plan and organize assignments and work under strict timelines is required

Internship, Medical Information & Drug Safety Resume Examples & Samples

Preparation of publications
Creation and analysis of inquiry statistics on a regular basis
Projects in cooperation with other departments like marketing, market access, quality and k key account managers
Good understanding of medical terminology
Sound knowledge of Microsoft Office applications
An "eye for detail"
Solution-oriented thinking and acting
Enthusiasm

100

Drug Safety Public Health Specialist Resume Examples & Samples

Safety Specialist, Operations Support team within DSPH Operations
Establishes work priorities and direction with input from Manager
Provides new hire (onboarding) Argus training within DSPH and CROs as required
Assists in development and maintenance of Ops Support training materials as required
Provides training to DSPH Operations personnel on data entry conventions as required
Assists with other Operations Support training activities as required
Performs quality control (QC) checks for data entered for ICSR reports from both investigational and postmarketing products to ensure accuracy and compliance with conventions and regulatory standards
Provides feedback on results of QC check to DSPH Operations Case Owners and Managers
Collates findings from QC checks
Seeks assistance from appropriate internal and external resources
Will interact with other DSPH functional areas to QC ICSRs efficiently and accurately
Identifies issues/concerns in a timely and appropriate manner and communicates these to Manager
Remains current with case handling SOPs, WRKs, manuals and database technology
Organizes individual workload to ensure compliance with PVA and other global regulatory reporting requirements
Understands DSPH Business Continuity processes, as applicable
Excellent interpersonal and communication skills, both written and oral
Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word)
Safety database, data entry and QC experience preferred
Training experience preferred but not required
Understanding of medical terminology and the ability to summarize medical information required
The ability to assess data and understand the medical/safety implications
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
Demonstrated success working both independently and in collaboration with others
A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required
Case processing experience is required
2+ years of drug safety experience and a BS degree in a life sciences field
3+ years of experience in the drug safety field and an AA degree
Experience in both clinical and post-marketing environment preferred

101

Manager, Drug Safety & Pharmacovigilance Resume Examples & Samples

HCP with 3-5 years of PV/Drug Safety experience
Clinical trial experience required
Knowledge in MedDRA and WHO drug coding
Must have excellent oral, written, presentation and computer skills
Experience in Argus Safety Database required
Knowledge of US, EU and other international PV regulations for drugs and drug-device combination products desired

102

Senior Manager, Drug Safety Quality Resume Examples & Samples

Ensure SABR is implementing and adhering to Development Sciences Business Processes requirements
Ensure a comprehensive training system governing the global PV systems in Collaboration with R&D Compliance, Corporate Quality and SABR management to develop and implement effective training programs and efficient training delivery and tracking mechanisms
Ensure a Records and Knowledge Management system is in place and consistent with R&D compliance documentation systems and in line with PV regulation worldwide
The Process and Records Management Manager will also be responsible for overseeing the development and management of the PSMF
Provide direct supervision and management of Process and Records Management Associates (including mentoring)
Ensure SABR is implementing and adhering to Development Sciences Business Process requirements
5 - 7 years experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences
Minimum of 3-4 years management and / or project management
Knowledge of FDA expectations is essential
Direct experience in GCP compliant quality systems

103

Specialist Drug Safety Resume Examples & Samples

Contribution to regulatory credibility through delivery of outstanding quality and compliance standards and process excellence in all Affiliate Drug Safety responsibilities
Contribution as subject matter expert for Affiliate Drug Safety when applicable
Contribution to the GDSRM ambassadorial role within the Affiliate as a drug safety member
Contribution to effective working partnerships in collaboration with key Affiliate Stakeholders, GDSRM, GDSRM EMEA/APAC and EU QPPV in support of Celgene’s PV (Drug Safety and Risk Management) System
Contribution to GDSRM continuous process improvement and leverage of innovation to drive technical and operational excellence in support of higher order Drug Safety and Risk Management throughout Celgene’s GDSRM Network
Pharmacy university degree
Excellent German and very good English language skills
Experience in pharmaceutical industry (pharmacovigilance preferred, alternatively medical information or regulatory affairs)
Experience in working with quality management processes and compliance monitoring
Experience with safety databases (data entry, report generation, ad-hoc querying)
Very good knowledge of PV legislation and requirements including broad appreciation of global regulatory requirements for PV and data protection requirements
Excellent working knowledge of AE processing
Very good knowledge of medical terminology
Very good knowledge of Microsoft Office and database skills
Very good communication and presentation skills
Commitment to follow Standard Operating Procedures
Must be able to work independently, take initiative, establish priorities, scheduling and meeting deadlines
Very good interpersonal, analytical and organizational skills
Decision-making capability

104

Drug Safety & Pharmacovigilance Resume Examples & Samples

Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems; acts as a primary point of contact for information regarding assigned projects; represents Safety and Pharmacovigilance on cross functional teams
Trains new staff; acts as the primary resource for other Safety Specialists with regards to answering questions, sharing knowledge and assisting in resolving problems; provides technical support
Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists, including but not limited to
Trains Investigators and other departments on AE reporting/adjudication

105

Drug Safety Manager Resume Examples & Samples

Management of Individual Case Safety Report (ICSR) from all Spontaneous and Solicited sources and from all clinical studies and solicited programs
Collects all Spontaneous adverse events reports associated with Roche products from all sources and Clinical adverse events reports for Roche sponsored and Roche supported clinical trials/studies and transmits the reports to Product Development Safety Operations (PDSO) Processing Centers according to internal guidelines and procedures
Performs diligent follow –up attempts to collect all necessary information for case completeness
Creates and maintains the product list for the management of local literature reports
Submits (electronically) all local spontaneous ICSRs to Greek Health Authority (also referred to as EOF) in a timely manner according to regulatory, local and global requirements
Management of Periodic Aggregated Case Reports (Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs)/Safety Renewals Packages)
Contributes to the Submission to EOF of all Periodic Aggregated Case Reports being under the responsibility of local DS & MI Unit such as PSURs/PBRERs by preparing the submission package
Liaises with local Regulatory Affairs Unit to provide support for periodic aggregated case reports under their responsibility (DS Updated Reports and Annual Safety Reports) if relevant
Safety oversight (i.e. appropriate PV language within contracts, Case Transmission Verification CTV, Source Data Quality Check SDQC,etc) for any other local activity handled in-and outside the Medical Affairs Department (Marketing, Sales, Epidemiology, Market Research and Patient Support Programs -MAPs, Compassionate Use Programs, Pre Approval Access Programs, Post Trial Access Programs, etc.)
As PV approver in the contect of MAPs assess the program design and other relevant documentation, and approves whether the program complies with global and local requirements
Management of Pharmacovigilance (PV) training and PV Regulatory Intelligence
Prepares training material for PV Training for non-safety Staff
Trains all Roche Hellas Staff (induction and regular refreshers) or any Third Party staff working on behalf of Roche Hellas on their obligations regarding transmission of safety information to the local DS & MI Unit
Ensuring adequate assignment Risk Management Plan of activities for all products
Acts as a Risk Management Plan (RMP) Implementation Coordinator (IC), the local named contact for the Headquarters (HQ) in the European Economic Area (EEA) Affiliate
Is the key contact internally and externally (e.g. inspection) for all RMP related questions for all products
Has the oversight of all RMP activities in the country and other territories of his/her responsibility (Greece & Cyprus) and is accountable for keeping the central tracker up to date with requested information
Serves as a Subject Matter Expert (SME) for Affiliate specif topics around risk management planning such as assessing the Risk Management strategy and upon request providing feedback on feasibility of proposed Risk Minimazation Activities (RMinA) to global safety teams. This activity has to be made in close collaboration with all other functions responsible for RMP implementation related activities (i.e.business, local brand team responsible, local Regulatory Affairs Unit, etc.)

106

Drug Safety Distributions Manager Resume Examples & Samples

Performs regulatory reportability and distributions activities
Experience: Four(4) years of relevant clinical experience. Two(2) years pharmaceutical/biotechnology industry experience. Drug Safety experience
Working knowledge: Mastery of global regulatory requirements for pharmacovigilance. Clinical knowledge of therapeutic area, patient populations, and drug class. Knowledge of computer and database skills
Competencies: Attention to detail, organization and planning, time management, data management, team work and strong communication skills

107

Drug Safety Public Health Coordinator Resume Examples & Samples

Responsible for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable SOPs and guidelines
Understand SDEA and global regulatory reporting timelines in order to prioritize cases if needed
Perform simple queries of the safety database, e.g. duplicate searches
Maintain and manage department Safety mailbox, distributing to relevant parties as applicable
May perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports)
May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries
Meet specific data and quality targets for case handling
Assist with tracking and reconciliation of incoming adverse event reports
Coordinate submission of product complaints to the Quality assurance department
Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessary
Recognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources
Assists Safety Specialists in sending and tracking follow-up letters
Remain current with case handling SOPs, guidance documents and database technology
May assist manager in the preparation of training material and assist in training new employees their functional area
May assist manager with writing/reviewing guidelines for their functional area of expertise
May assist with other projects as necessary (i.e, study un-blinding, reconciliation with vendors, etc)
Ensures departmental workflow processes and timelines are followed
Excellent interpersonal communication skills, both written and oral
Excellent computer skills in MS environment (MS Excel, Power point and Word)
Safety database and data entry experience preferred
Demonstrates initiative, teamwork and accountability
Strong organizational skills, and ability to adapt to change
A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required
Ability to follow guidelines and procedural documents
Industry experience in the health, clinical, bio-pharmaceutical, or relevant industries such as, pharmacy technician, nursing assistant is valuable but not required.Search Jobs US

108

Medical Information & Drug Safety Coordinator Resume Examples & Samples

Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; tracking timelines for completion of event processing; distributing event information to appropriate project personnel in the workflow for continued processing; review and preparation of endpoint documentation; transfer of events to client and other parties as identified by operations lead; obtaining confirmation of report receipt and track submission; and assuming workflow responsibilities for various projects
 May assist with project workflow including database entry, quality control activities, generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submission dossiers, assisting with deadline quality measurements, as directed by operations team member or manager
 Assist with administrative team support e.g. project start-up tasks, creation and maintenance of project files, systems access requests; periodic distribution of AE listings; and shipping of information supplies to sites as directed by senior operations team member
 May coordinate, schedule and submit safety reports to regulatory authorities, marketing authorization holders, investigators, customers and operations team in accordance with deadlines; perform project administrative tasks such as creation of labels using investigator list, maintenance of personal safety files for mail merges and regulatory documents, copying of documents, envelope stuffing, tracking and filing of submission dossiers, and distributing listings to client and/or operations team members
 Creating, maintain and track case folders; filing, retrieving and distribution of case folders to operations team members; assisting in maintenance of document control storage and relevant applications/systems as directed. Archiving case folders and project files after event closure; coordination of transfer of archived material to company/customer archive storage facilities after study closure; assisting in creation of records management processes and procedures; providing key input to operations team on acquisition and/or upgrade of records management application/systems; and serving as liaison between Lifecycle Safety department and records management department
 May assist with system support tasks such as utilizing design specifications, study form, and protocol to create project specific entry specifications and annotated project forms for database under guidance from operations lead and/or manager; creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation through performance of user testing; performing ad hoc database searches for operations team leads; assisting operations team member in assessing database setup needs; assist with project phone/fax line set-up as required; escalating any system/equipment problem
 Oversee and co-ordinate administrative support by coordinating team/department/customer/project oversight group meetings, coordinating stationery orders, dispatching documents via courier services, reserving meeting rooms and IT equipment; and providing administrative support where required
 Identify and record process or quality problems and bring them to the attention of a senior team member
 Provide training/mentoring to new/less experienced staff
 Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing
 Co-ordinate, oversee and delegate resource tasks to administrative team members as appropriate and monitor the intake of cases and archiving process when multiple coordinators are involved
 Involvement and contribution in local/global department committees e.g. Engagement, Admin, Quality initiatives
 Good understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Standard Operating Procedures (SOPs) and work instructions applicable to the role
 Good working knowledge of Microsoft Office and web-based applications
 Good knowledge of medical terminology
 Strong organizational skills and time management skills
 Strong verbal/written communication skills
 Self-motivated and flexible
 Excellent attention to detail and accuracy
 Ability to follow instructions/guidelines, utilize initiative and work independently
 Proven ability to multi-task, manage competing priorities and deadlines
 Ability to delegate and mentor effectively to less experienced team members
 Willingness and aptitude to learn new skills across all Lifecycle Safety service lines

109

Drug Safety Officer Resume Examples & Samples

Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
Carry out all case management activities as appropriate
Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
Ensure complete and timely forwarding of ICSR to Core
Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
Consistently apply regulatory requirements and company policies
Analyze and monitor activities, define and implement corrective actions, where applicable
Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
Provide oversight and team mentoring on case handling aspects, data extraction and analyses
Manage, where applicable, safety resources in the local team
Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the GPO DSU organization
Act as subject matter expert for the DSU within WSR
Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
Promote/participate, as appropriate, in local, internal and external safety activities
Minimum of a Bachelors degree, preferably within a scientific or healthcare discipline
Solid working knowledge of pharmacovigilance concepts, medical terminology, national and international regulations, and global regulations and guidelines for drug development
Understanding and ability to use computer technology, management of relational database systems, including extraction of data
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110

Drug Safety Officer Resume Examples & Samples

Bachelor’s/BSN degree (or higher) in a related medical field with sound knowledge of biomedical sciences and therapeutic principals (licensed professional with advanced degree preferred)
5 years Drug Safety, Medical Information or Pharmaceutical related experience of which 4 years must be in Drug Safety
Scientific background in CNS and/or Immunology helpful
Knowledge of FDA PV requirements
Line management experience preferred

111

Drug Safety Support Specialist Resume Examples & Samples

Maintenance of adverse event tracking systems
Set-up and maintenance of project files, core process files and central safety files
Assist with the reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA) / Senior Drug Safety Associate (Sr. DSA)
Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA/Sr. DSA
Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs))
Assist the DSA/Sr. DSA in preparation of materials needed for client and/or investigator meetings
2 years of office experience
Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data

112

Director, Drug Safety & Pharmacovigilance Resume Examples & Samples

Manage the relationship with pharmacovigilance providers, Clinical Study CROs and internal Medical, Safety and Clinical personnel
Contribute to the development, production and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the pharmacovigilance activities
Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns
Contribute to development & maintenance of product safety profile
Support and/or draft regulatory inquiry responses related to pharmacovigilance / safety issues to regulatory agencies, EC/IRB, Investigators and ad hoc inquires
Track events of special interest and assist in development and maintenance of standardized queries for events of special interest
Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc.) related to pharmacovigilance
Perform follow-up on pending Corrective and Preventive Actions (CAPAs) and ensure implementation of the same in the Global compliance database
Perform compliance data analysis using available tools to identify potential trends
Perform literature search and review and able to effective determine appropriate and relevant literature for the purposes safety analysis
Support the conduct of PV audits/regulatory inspections
Participate to the Development of compliance programs and quality tools to enhance global quality and adherence to SOPs and Regulations
Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with partners
Doctor of Medicine (MD) degree required, preferably with board certification
Minimum 10 years of experience in pharmacovigilance activity also required
Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety repo environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines
Working knowledge of MedDRA dictionary is necessary
Familiarity with common Safety databases (e.g. ARIS, etc.) is preferred
Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case proc submission
Ability to read and collate scientific and medical literature is also required Proven ability to work on multiple projects
Excellent computer skills; email and Internet and Adobe Acrobat are required Action orientation combined with high ethical standards is critical
Efficiency, detail-oriented orientation, flexibility and the ability to meet tight deadlines is essential Excellent communication, organizational, planning, and follow-up skills are needed
Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, with any other position specific competencies
Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

113

Senior Drug Safety Response Associate Resume Examples & Samples

Monitor LAM and Central worklist for follow-up action item requests
Create the appropriate type of follow up action items (HCP letter, consumer letter, Clinical Trial letter, Emails, etc.) and assign to the appropriate individual for processing
Schedule re-evaluation of follow up requests to determine if required number of follow-up attempts have been fulfilled, according to Bayer and regulatory requirements
Generate calls to consumer’s, healthcare providers and our licensed partners in order to obtain critical follow-up Adverse Event information
Monitor the Drug Safety Response Center mailbox for incoming requests and inquiries and initiate the appropriate process for obtaining follow up information from HCPs and consumers
Communicate and collaborate with Global and Local colleagues related to safety issues, clarification of requests and encourage open communication to achieve mutual understanding of issues/seek resolution
Work cooperatively toward the identification of areas needing improvements, make valuable suggestions for improvement and develop continuous improvement methods in order to increase proficiency, accuracy and improve overall compliance within the department
MS degree in Life Sciences, RN, RPH/Pharm D with 2 years of Pharmacovigilance (PV) experience OR Bachelor’s degree in Life Sciences; with 3 years of PV experience
Demonstrate problem solving skills, especially with respect to enforcing safety rules and global procedures, as described in SOPs, Operational Manuals and Guidance documents
Excellent written/oral communication skills are essential including fluency in English
Proactive behavior and ability to keep timelines
High degree of responsibility and accountability
Ability to develop cooperative working relationships with all levels of staff is critical
Global drug safety database knowledge
Experience with global adverse event coding, MedDRA coding
Experience with Medical Devices
Experience with consumer care products

114

Home-based Drug Safety Manager Resume Examples & Samples

Oversee clinical safety case management and aggregate reporting responsibilities of line reports to ensure client needs are fulfilled to high quality
RN or equivalent healthcare experience with a bachelor's degree
At least 4 years of drug safety experience in a CRO; and
At least one year of project management experience
Willingness to travel to corporate headquaters and other meetings as necessary

115

Drug Safety Manager Resume Examples & Samples

Manage relationships with clients and internal stakeholders by providing expert safety knowledge
Create safety management plans dependent upon client
Provide safety review of clinical study documents, including protocols, study reports; and marketing application components
RN or equivalent healthcare experience with a bachelor’s degree
At least one year of clinical experience
At least 4 years of clinical research experience; and

116

Director, Drug Safety Resume Examples & Samples

Lead the ongoing process enhancements for safety surveillance, including development of standard operating procedures and work instructions and templates
Establish the necessary quality control and monitoring processes to oversee compliance of vendor work relating to adverse event case management and ICSR processing
Support audits/inspections of systems and procedures to ensure quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to regulatory findings relevant to safety operations and processes
Contribute to safety analyses in Regulatory submissions (e.g. MAAs, NDAs), publications and presentations
Participate in the development of safety surveillance and risk management plans for development programs
Liaison with partner company’s drug safety team and clinicians and provide regular safety summaries as required
Participate and assist in overall signal detection activities including monitoring, evaluation, interpretation and appropriate management of safety information
Participate in cross-functional project teams; provide safety update and ensure adequate safety support cross functionally
Ensure accuracy and timeliness of submission of expedited reports from clinical trials
Perform listing reviews and data validation in support of the medical coding group
Provide clinical education support for internal stakeholders
Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e. through review of scientific journals, attend scientific and key technical meetings etc.)

117

Data Entry Coordinator, Global Drug Safety Resume Examples & Samples

BS or equivalent in a health related setting (or equivalent combination of education and experience)
Minimum 3 years of related experience in clinical records/data processing/medical transcription setting
Familiarity with the use of databases
Records management experience
Knowledge of Medical Terminology
Knowledge of laboratory and diagnostic testing

118

Associate Director / Director, Drug Safety Resume Examples & Samples

Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma
Conduct medical review of individual case safety reports (ICSR) within workflow timelines and per ICH-GCP guidelines, regulatory requirements and company’s SOPs
Perform quality control review of all SAE cases to ensure medical accuracy, integrity and completeness of information reported and entered in the safety database
Contribute to the review, development, and reporting of drug safety information to regulatory authorities, including but not limited to individual case safety reports (ICSRs), INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports
Provide guidance and review of safety section(s) of study protocols, IC, forms, IB/DCSI updates, SPI, etc
Interact with business stakeholders, CROs, etc., for assigned products and clinical programs. Participate in meetings for different clinical programs
Perform routine surveillance review and evaluation of safety aggregate data as part of routine and ad-hoc signal detection activities and contribute to the development of risk management plans
Contribute to the development, review, and update of new Drug Safety/Pharmacovigilance SOPs, drug safety processes, Safety Data Exchange Agreements. and other safety related tasks to support the development of the department infrastructure
Participate in the organization and maintenance of safety information
M.D. or Pharm.D. degree highly preferred, specialization and/or experience in oncology or hematology preferred
Minimum of 12+ years of safety/pharmacovigilance hands on experience in clinical and post-marketing with global product responsibility
Excellent knowledge and understanding of FDA, EU and ICH guidelines and regulations governing clinical trials and post marketing safety
Great knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry
Ability to evaluate and interpret medical clinical and scientific data
Excellent clinical judgement and ability to articulate complex clinical issues in a scientifically sounds and understandable way
Subject matter expert in performing medical review of all types of ICSRs from all report sources
Experience in Safety systems (either Argus or AERS, ARISg) and understanding of aggregate data is required
Hands-on experience with case evaluation, signal detection activities, including analyzing/categorizing/assessing data
Understanding of Pharmacovigilance Operational activities
Excellent interpersonal and written communication and ability to influence others
Demonstrate cross-functional collaboration, ability to work effectively in a team setting to resolve issues and reach solutions
Demonstrated ability to utilize effective critical thinking and problem-solving skills
Expertise in MedDRA dictionary relevant to AE/SAE coding
High attention to detail and accuracy
Strong commitment to business ethics

119

Global Drug Safety Compliance Lead Resume Examples & Samples

50%
Bachelors of Science degree preferred in medical or science-related field
5+ years in pharmaceutical industry preferably in pharmacovigilance, Quality Assurance, or similar department
Strong understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
Experience with databases (TrackWise, Argus, etc.) and electronic document management systems
Ability to interpret PV regulations and analyze gaps and identify opportunities to implement
Ability to identify resolutions and to resolve conflicts with direction from management

120

Associate Director Drug Safety Operations Resume Examples & Samples

Be point of contact for health authority inspections and audits with regards to certain operational policies and procedures
Attend meetings, conferences and forums in order to keep current with industry trends on systems and technology and using this knowledge to influence decision making and enhancements to Bayer pharmacovigilance systems and processes
Serve as the point of escalation for any compliance failure related to Intake or follow-up and implement corrective and preventive actions (CAPA) to ensure future compliance
Responsible for the management of the Drug Safety Response Center members and workflow
Monitor both the Central and Local Affiliate Module (LAM) work lists for follow-up action item requests
Create the appropriate type of follow up (Heath Care Provider (HCP) letter, consumer letter, Clinical Trial letter etc.) and assign to the appropriate individual for processing
Schedule and re-evaluate follow up requests to determine if required number of attempts have been fulfilled, according to Bayer policies and procedures
Generate calls and emails to consumers, healthcare providers, investigators and our licensed partners in order to obtain follow-up Adverse Event information
Create and email Clinical Trial letters to the study sites to request follow up information on study participants
Monitor the Drug Safety Response Center mailbox for incoming requests and inquiries and initiate the appropriate process for obtaining follow up information from HCPs, investigators and consumers
Communicate and collaborate with global and local colleagues related to safety issues, clarification of requests and encourage open communication to achieve mutual understanding of issues and resolutions
Be responsible for the management of the Intake Group members and workflow
Be responsible for cross training of the Intake Group
Maintain compliance for source documents received in accordance with FDA Regulations
Identify and resolve issues within the Intake Group
Support the creation and maintenance of Operating Instructions (OI) and/or Standard Operating Procedures (SOP) for Intake Group
Monitor and maintain the GPV_US mailbox
Monitor Right Fax Utility daily and upload accordingly within Documentum
Manage source documents going to the file room
Collaborate with the Drug Safety Response Center regarding follow-up letters
Ensure all reconciliations for Right Fax, IRMS, and LASH are completed in a timely manner
Ensure all follow-up letters are completed and mailed daily
Collaborate with Medical Communication (and/or other partners) on the identification and resolution of issues
Master’s degree in business or life sciences and at least five (5) years’ experience in Pharmacovigilance (PV) or Clinical Development or Pharm D, Ph.D. degree with four (4) years of experience in Pharmacovigilance/Drug Safety or M.S., B.S. R.P.H., RN Bachelor’s degree in business or life sciences and at least six (6) years of experience in Pharmacovigilance or Clinical Development/Drug Safety
Demonstrated ability to solve complex problems independently
Deep understanding of Global Regulatory (ICH/FDA/EMEA) guidelines
Deep knowledge of Global PV functions & processes, with ability to interpret, document and improve
Expert usage and understanding of medical terminology
Accomplished and very good/expert knowledge in MedDRA coding using terminology prescribed by global regulatory authorities
Very good knowledge of compliance relevant regulatory obligations regarding pharmacovigilance, specifically reporting rules and timelines
Analytic, systematic and strategic thinking
Proven ability to work in international teams with members from different cultural backgrounds
Excellent negotiation, presentation and communication skills
The aptitude to organize, analyze and summarize information and communicate results
The ability to develop cooperative working relationships with all levels of staff, including external partners
Ability to influence without authority
Two (2) years or more of management experience

121

Senior Drug Safety Physician Resume Examples & Samples

Provide support to the Drug Information &Pharmacovigilance Product Support (call) Centre and the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile
Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON
Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
Review and provide input to the Project Specific Procedures and participate in project related meetings
Communicate with the client to an extent as described in the Project Specific Procedures
Provide assistance in the preparation and conduct of code-break activities
Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project
Medical Degree from an accredited institution of Medical education
The successful candidate will ideally have 1 or more years of clinical research or industry experience
You will have excellent verbal and written communication (English and local language) combined with excellent computer skills; Excel and Access skills preferred and basic presentation skills

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