Drug Safety Specialist Resume Samples

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O Kunze

Oma

Kunze

5886 Lang Squares

Dallas

+1 (555) 642 5615

5886 Lang Squares

Dallas

Phone

p +1 (555) 642 5615

Experience Experience

Houston, TX

Drug Safety Specialist

Houston, TX

Goyette-Mante

Houston, TX

Drug Safety Specialist

Ensures incoming Adverse Events are processed accurately, providing internal feedback and training to maintain quality and compliance to regulatory timelines
Responsible for coordination activities for Safety Management Team meetings including: preparation of the agenda, slide presentations and recording of minutes
Involved in Quality checking various safety activities including data entry
Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs), and project specific safety plans
Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet
Assists training of Investigators and other departments on AE reporting/adjudication
Support senior team members in training activities related to Drug Safety & AE reporting both internally and externally

San Francisco, CA

Medical Information & Drug Safety Specialist

San Francisco, CA

Gerlach, Kozey and Hermiston

San Francisco, CA

Medical Information & Drug Safety Specialist

Identifying Individual Case Safety Reports and technical product complaints and forwarding them to the relevant stakeholders within pre-determined timelines
Maintaining a library of responses to Frequently Asked Questions and of Standard Response Letters
Perform Canada vigilance Screening
Participate as an active member of multidisciplinary teams to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors
Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners, regarding marketed products, investigational compounds, clinical trials and other product information
Process individual Case Safety Reports (ICSRs), including data entry in the electronic database
Entering information for medical information enquiries into medical information databases, tracking systems and project-specific forms ensuring accurate data-entry

present

Dallas, TX

Senior Drug Safety Specialist

Dallas, TX

Kuphal, Lueilwitz and Bergnaum

present

Dallas, TX

Senior Drug Safety Specialist

present

Working knowledge of MedDRA and WhoDrug coding principles and practical applications
Performs other duties as assigned
Assist with AE/SAE reconciliation prior to clinical trial database closure
Perform initial assessment to determine if the case meets criteria for adverse event of special interest (AESI)
Review source documents and ICSR information in order to verify accuracy, completeness and consistency. Perform Quality Control on cases processed by other team members
Manages business partner exchange of AE reports in accordance with safety data exchange agreements and performs reconciliation
Provide scientific support to project team involved in the application of cognitive computing and other artificial intelligence capabilities to be used in the conduct of pharmacovigilance

Education Education

Bachelor’s Degree in Medicine

Howard University

Bachelor’s Degree in Medicine

Skills Skills

Knowledge: Clinical knowledge of therapeutic area, patient populations and drug class
Good communication skills, including good written and spoken English
Knowledge of and ability to interpret and apply global safety regulations
Basic knowledge of Microsoft Office applications
Very strong attention to detail
Excellent computer skills with full proficiency of MS-Office Applications
Good clinical knowledge of therapeutic area, patient populations and drug class
Knowledge of GXP Scope (Good Pharmacovigilance Practice)
Working knowledge of ICH/GCP guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries
Ability to train and mentor people

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Drug Safety Specialist Resume Examples & Samples

Manage collection, processing, documentation, reporting & follow-up of all serious adverse events (SAE) reports for all Novartis products from clinical trials, and all adverse events from Patient Oriented Programs, post-marketing studies (PMS), registries, and all Spontaneous Reports (SR)
Transcribe, translate and enter data of all SAE (from Clinical Trials), AE (from Patient Oriented Programs, PMS, registries and all SR from source documents onto systems accurately and consistently with emphasis on timeliness and quality
Record and track receipts, submissions and distributions of SAEs, SRs, Investigator Notifications (IN), SUSARs, Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR) in cooperation with other CPO Departments (Depts)
Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other CPO depts
Work with other local/global PVO associates to ensure accurate evaluation of safety data
Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and 3rd party contractor, if applicable
Survey and monitor national pharmacovigilance (PV) regulations and provide update to global PVO organization
Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements
Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of AE information
Perform reconciliation with other depts for potential AEs resulting from medical inquiries and quality related complaints
Management and maintenance of all relevant PVO databases
Develop and update training materials for PV and ensure training of CPO associates on relevant PVO procedures for AE reporting, including field force and 3rd party contractor, if applicable
Manage and maintain efficient PVO filing and archive system
Review of all Phase IV Clinical Trial and PMS protocols safety sections and if a Contract Research Organisation (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
Drives the local execution of the RMP for all Gen Med and Oncology Pharma products in CPO
Ensures training on RMP principles and product specifics of CPO staff involved in the implementation of the RMP
Supports the Drug Safety Responsible in the timely and compliant execution locally of the PV activities defined in the RMP
Liaises with the other departments in the CPO such as CRO, Medical, Regulatory Affairs or Sales/Marketing to ensure alignment of all local functions in support of the RMP
Liaises with Sales/Marketing to ensure implementation of educational materials
Liaises with Local DRA to ensure tracking of status of the RMP commitments implemented locally

Drug Safety Specialist Resume Examples & Samples

Bachelor’s degree in Nursing, Pharmacy or health-care related field required
Minimum of two to four years drug safety experience in a biotechnology or pharmaceutical company
Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries
Familiarity with the following: safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development
Basic knowledge of cGXPs
Working knowledge of Demonstrated Good Documentation Practices
Fluent in medical terminology
Must be proficient in MS Office Suite
Ability to interpret and follow regulatory guidelines
Ability to manage both day-to-day operations as well as project work in a fast paced environment
There is minimal travel for this position; the average travel is 5-10 with some variation based upon the demands of the business imperatives

Drug Safety Specialist Resume Examples & Samples

Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, Alkermes SOPs, and applicable licensing or partnership agreements
Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all post-market and clinical safety pharmacovigilance activities are performed across ongoing projects independently
Perform verification of safety data and will utilize clinical judgment in coding of verbatim adverse events, medical history and medications. Ability to synthesize complex clinical information into accurate and complete reports
Actively obtains follow-up through event resolution. Performs SAE reconciliation, ensuring completeness and closure of cases in a timely fashion
Performs continuous quality improvement initiatives to ensure data consistency across products and a high level of data quality
Contributes in the conduct of ongoing safety surveillance for marketed and investigational products. Assist with the identification and evaluation of events of special interests as well as aggregate data review
Interpret regulatory mandates
Assist with internal and external drug safety audits
Participate in clinical project teams and other interdepartmental teams supporting clinical studies; reviews and provide comments on study related documents
Acts as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites; interface with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal
Contributes in the development and writing of industry standard operating procedures and processes for pharmacovigilance activities including writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports
Identify and correct actions and facilitate, support, and implement as appropriate
Review performance metric data and clarify inconsistencies and trends
Address labeling concerns and updates
Assist in responding to queries from health authorities or outside sources; Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, PSUR, or clinical study reports
4+ years drug safety or clinical safety experience
Experience with Argus Safety System
Knowledge of clinical trial database (e.g. Trialmaster) is a plus
Ability to work effectively as an individual contributor and as project team safety representative
Has the ability to work independently and multi-task with attention to detail,

Drug Safety Specialist, Global Drug Safety Resume Examples & Samples

Two (2) years relevant clinical experience or relevant scientific background equivalency
Two (2) years relevant experience in the Industry, drug safety experience preferred
Data entry/data management or document management experience
Clinical knowledge of therapeutic area patient populations and drug class, Oncology and I&I experience preferred
Computer and database skills preferred, Familiarity with the ArisG safety database preferred
Working knowledge of MedDRA and WHODRUG coding dictionaries and medical terminology
Working knowledge of global regulatory requirements for Pharmacovigilance (i.e. relevant FDA, EMA and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments

Senior Drug Safety Specialist Resume Examples & Samples

Knowledge of the clinical areas for which Mallinckrodt markets products. Knowledge in the review and analysis of the medical literature
Demonstrable skills in reviewing and summarizing medical records
Excellent verbal and written communication skills including excellent telephone etiquette. Must be comfortable handling discussions with patients and health care providers on health and medical topics
Strong experience in computer applications such as Microsoft Word, Excel, and Power Point, and a willingness to expand and increase competencies
Extensive experience in the reporting as well as managing of adverse event reports
Experience in writing safety summaries

Drug Safety Specialist Resume Examples & Samples

Excellent knowledge of and ability to interpret and apply global safety regulations
Experience in data analysis, evaluation of safety data and the preparation of safety reports
Excellent presentation skills
Excellent organizational and prioritization skills
Excellent team/project leadership and delegation skills
Ability to train and mentor people
Experience with computer applications including database management and pharmacovigilance systems

Drug Safety Specialist Resume Examples & Samples

Fully participates in daily case processing activities and assist other associates with case and workflow management. Participates in QC activities
Interfaces with other departments to facilitate information exchange and communicates information to ensure clear and consistent reporting
Creates or updates SOP/WI as required by manager

Drug Safety Specialist Resume Examples & Samples

Support data reconciliation from safety reports and clinical trial databases
Provide internal training, as appropriate
Life Science Bachelor’s degree with a minimum of 1 year related experience preferred
Excellent knowledge of FDA safety reporting requirements
Critical thinking skills are required
Ability to work under pressure and independently
Computer/word processing expertise

Drug Safety Specialist Resume Examples & Samples

Management of Adverse Event (AE) case data through the receipt ad triage of local AE reports received from Health Care Professionals or consumers. Reporting of such to Global Safety via the global safety database
Initiation and conduct of follow-up activities related to local AE reports including direct telephone follow-up as required
Assessment of local and global clinical trial and post marketed serious AE reports for submission to Health Canada in accordance with federal requirements. Provision of support to the Submissions Associate for all submission activities
Support senior team members in training activities related to Drug Safety & AE reporting both internally and externally
Assist senior team members in the management and maintenance of good customer relationships both internally with the Celgene Affiliate office and externally with key customers
Assist in responding to safety inquiries received from Health Care Professionals or Health Canada
Maintenance of high compliance standards with respect to reporting timeliness and quality of local AE data. Ensuring all standard operating documents are followed and that the department is inspection/audit ready at all times
Champion Celgene Values
A health professional background, preferably a degree in Pharmacy or Nursing
Two years clinical experience preferred
Good clinical knowledge of therapeutic area, patient populations and drug class
Excellent computer skills with full proficiency of MS-Office Applications
French language skills preferable
Knowledge of Health Canada requirements with respect to ADR Reporting and Pharmacovigilance activities
Self-starter with superior time management skills, and ability to work independently or in team
Very strong attention to detail
LI-EX

Drug Safety Specialist Resume Examples & Samples

Demonstrated knowledge of domestic and international regulatory safety reporting requirements. Must have excellent, concise writing skills
BS Pharmacy, PharmD, PA, BS RN degree with critical care management background preferred, MD or equivalent training
Drug Safety Specialist I-II: Minimum of 2-3 years of experience in a biopharmaceutical or clinical research environment.Drug safety experience is preferred
Sr. Drug Safety Specialist I-II:Minimum of 2-3 years of Drug Safety experience

Drug Safety Specialist Resume Examples & Samples

Develop Expedited Reporting Procedures
Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local
Experience with computer applications including database management and pharmacovigilance systems- ie.Argus or Aris G

Drug Safety Specialist Resume Examples & Samples

Certificates, Licenses, Registrations
At least one of the following: LPN, RN, RPh, PharmD, P.A. or MPH is required
Bachelor's degree in Nursing, Pharmacy or health-care related field required
Completes data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources
Conducts complete clinical reviews of all domestic and foreign adverse event reports for all Client investigational and marketed products
Ensures consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility
Performs active follow-up, including both written and verbal communication with healthcare professionals and consumers
Interprets source documentation including relevant medical conditions, lab results and procedures to compile complete and accurate narrative summaries
Exercises judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements
Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet
Produces Clinical Safety Queries as needed for clarification of reports
Serves as a Safety Liaison contact to other departments and Client licensing partners
Interacts on a regular basis with Clinical Project Mgrs, Case Processing Mgrs, and Medical Affairs to identify process improvement strategies and communicate project status updates
Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues

Drug Safety Specialist Resume Examples & Samples

Minimum of B.S. Nursing Qualification or the equivalent combination of relevant education or professional experience
Two years of relevant clinical experience or relevant scientific educational background equivalency
Computer and safety database skills; Familiarity with the ArisG safety database a bonus

Drug Safety Specialist Resume Examples & Samples

Provides assistance and advice to Internal and External customers (e.g. Medical Information, Regulatory, Clinical Colleagues and other team members) on incoming Adverse Events, data capture/assessment and submission issues
Provides assistance and advice to Internal and External customers (e.g. Business Operations, Strategic Insights & Analysis and external service providers) on Market Research and Patient Support Program pharmacovigilance requirements
Assumes the leadership and/or contributes to projects relating to departmental processes. Works proactively and independently with minimal supervision on such projects. Keeps Managers regularly updated on progress
Understands the reporting requirements for the MHRA and submits reports correctly and in a timely manner
Involved in Quality checking various safety activities including data entry
Reviews and writes controlled documents for assigned process as appropriate
Provides Adverse Event Training to Welwyn site and external vendors when necessary
When requested by Team Manager, supports team during audits/ regulatory inspections

Drug Safety Specialist Resume Examples & Samples

Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists
Generates reports to clients and regulatory authorities as needed
Assists training of Investigators and other departments on AE reporting/adjudication

Senior Drug Safety Specialist Resume Examples & Samples

Play an active/leading role in cross-functional teams on safety matters/DS&E special projects
Conduct training and provide mentoring of team members and other line functions/business units and vendors (e.g. Clinical research, DRA, sales, consumer interaction, Pharmacies, etc)
Work closely with the Group Head/DSR to allocate and monitor resource requirements including: co-coordinating activities involving the teams in DS&E, other line units, and/or contractors utilized to augment the regular DS&E staff. Activities may be related (but not limited) to administrative functions, training of other team members, or leading targeted drug-specific data collection efforts. 4. Evaluate, coordinate, and /or manage the collection, documentation, triage, translation (if applicable) processing in Novartis Safety Database, transferring to Central Processing sites (if applicable), follow-up, submission/distribution to local health authorities or ethic committees (if applicable) and archiving of all safety reports for all Novartis products (drugs and devices) from pre and post-authorization (as applicable) phase according to the defined timelines and quality parameters
Determine the necessity for follow-up and prepare and / or perform follow-up as required by local SOP, or by direction of designated parties. (Medical function, Health Authorities, etc.)
Perform Health Authority expediting activities of individual case reports, and/or periodic safety reports as required by local regulation
Provide support for any internal or external pharmacovigilance audits and support (if applicable) and in the implementation of any corrective/preventative action as determined by auditors/ inspectors
Create and update product-specific documents as required by the health authorities
Acts as DSR Deputy: *functional (in terms of responsibility for PV system) and operational (in terms of managing the DS&E Team)
Activities under responsibility performed according to established objectives and directives from global and local SOPs and local regulatory requirements. 2. Organization and management of pharmacovigilance operations
Results of audits/inspections
Customer feedback

Senior Drug Safety Specialist Resume Examples & Samples

Manages CRO case processing activities in the safety database with respect to compliance with safety agreements. Interacts with the daily operations of a contract research organization (CRO). Active participation in quality assurance and archival of safety data
Prepares SOP’s and work practice documents
Bachelor’s degree required in a health care discipline. BSN, PharmD, PA preferred
4 to 6 years clinical safety or pharmacovigilance experience
Ability to analyze laboratory data and review source documentation of ICSRs. Strong ability to construct narrative summaries of AE data from source documentation. Knowledge of regulatory reporting requirements and formats for the FDA and international regulatory authorities. Computer skills including knowledge of databases and querying databases for preparation of data analysis. Experience with adverse event coding dictionaries (MedDRA)
Bachelors degree required in a health care discipline. BSN, PharmD, PA preferred
Strong knowledge of safety monitoring and pharmacovigilance. Experience in medical writing, strong interpersonal and communications skills, as well as organizational and problem-solving skills. Ability to collaborate and interact with a wide range of health professionals and company personnel. Knowledge of preparation of periodic safety reports required
Strong knowledge of FDA regulatory reporting requirements and GMP as well as GCP guidelines. Strong interpersonal, communication and organizational skills
Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
Ability to write periodic safety reports. Must have excellent written and oral communication skills
Must have resourcefulness and personal organization skills
Applies critical thinking skills to solve problems by generating, evaluating, and implementing solutions
Be open to considering new ways of doing things and the merits of new approaches to work
Work effectively with multi-disciplinary teams. Use teamwork skills to achieve goals, solve problems, and manage conflict
Take responsibility for accomplishing work goals within accepted timeframes
Pursue work with energy, drive and effort to accomplish tasks. Take initiative in seeking out new responsibilities and work challenges

Drug Safety Specialist Resume Examples & Samples

RN or Pharmacist/PharmD with minimum of 3 yrs. clinical exp. & Minimum 5 yrs. of related exp. supporting PV in pharma environment
Expertise with PV clinical and safety databases (e.g., structure and conventions)
Exp. in MedDRA coding and search strategies
Exp. in safety data analysis and writing safety assessments
Literature search, evaluation and assessment skills & presentation skills
Runs/supports routine signal detection processes in partnership with Risk Management
Responsible for coordination activities for Safety Management Team meetings including: preparation of the agenda, slide presentations and recording of minutes
Authors safety section in collaboration with team members on regulatory responses, IBs/CCDS, study protocols, CRFs, and other documents
Assists Risk Management Lead to oversee risk minimization activities including tracking of activities as needed

Drug Safety Specialist Resume Examples & Samples

Ensure that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements
Maintain oversight of safety risk management and all other pharmacovigilance (PV) activities and ensures PV compliance and inspection readiness across all affiliate functions
Ensure the writing of Aggregate Reports for local products, when applicable, in collaboration with Local Regulatory Affairs
Ensure the implementation and maintenance of a PV Quality System in the affiliate in accordance with global Roche and local regulatory authority requirements
Assume responsibility for educating and training relevant personnel in the affiliate

Drug Safety Specialist Resume Examples & Samples

9+ Years of Exp
Specific pharmacovigilance experience (drug safety)
Global regulatory reporting, Clinical Trials & Post-Marketing
Narrative writing & Literature review
Follow-up & query process, Understanding of Product Quality Complaints and Lack of effect

Drug Safety Specialist, Novartis, Norway Resume Examples & Samples

A degree within natural science (i.e. biology, chemistry, medicine or pharmacy)
Ability to lead and deliver initiatives
Attention to detail and quality focused
Good organizational, planning and prioritizing skills

Drug Safety Specialist Resume Examples & Samples

Support activities required for root cause analysis and CAPA monitoring
Support the production of compliance metric reports
Support the production of quality metrics reports
Liaise with LDSO Drug Safety Managers and Case Management staff to resolve potential compliance findings
Support QA random samplings
Support the review of local ICSR 15-day submission decisions
Support maintenance and contribute to the development of QA Tracking Log
Support the development of quality performance metrics and analysis of quality issues
Support the identification and tracking of action items and plans to correct quality issues
Support activities required to monitoring compliance of PV related contractual obligations including report reconciliation
May support administrative elements of Safety Operations Training processes
May support the execution of departmental projects

Senior Drug Safety Specialist Resume Examples & Samples

Lead and participate in scientific investigations of drug-related problems
Provide pharmacological and or medical expertise in scientific projects
Participate in routine signal detection and analysis, including causality assessment of case series
Provide scientific support to project team involved in the application of cognitive computing and other artificial intelligence capabilities to be used in the conduct of pharmacovigilance
Coordinate and contribute to international collaborative projects
Author scientific publications
Present research results internally and externally

Drug Safety Specialist Resume Examples & Samples

Liaises with Internal and External customers (e.g. Medical Information, Regulatory, Clinical Colleagues and Service Providers) to support processes relating to Adverse Event and Product complaint reporting
Ensures incoming Adverse Events are processed accurately, providing internal feedback and training to maintain quality and compliance to regulatory timelines
Uses expert knowledge to assess Individual Case Safety Reports (ICSRs) and ensures timely submission to MHRA
Provides support and advice to Internal and External customers (e.g. Business Operations, Strategic Insights & Analysis and external service providers) on pharmacovigilance requirements. Assesses activities requiring pharmacovigilance reporting such as: Market Research, Patient Support Programs, Non-Interventional Studies and Digital multichannel activities
Involved in Quality checking various safety activities including data entry, submission decisions, trial documents, contract wording and source data from solicited sources
Identifies and escalates internal gaps and non-compliance to ensure corrective and preventative actions are planned and implemented
Provides Adverse Event Training to Welwyn site and Service Providers when necessary
Supports team during audits/ regulatory inspections
Assumes leadership and/or contributes to projects relating to departmental processes. Works proactively and independently with minimal supervision. Keeps Managers regularly updated on progress and escalates issues in a timely manner

Drug Safety Specialist Resume Examples & Samples

This is a 1 Year Contract **
A health professional background, preferably a degree in Medicine, Pharmacy, or Nursing
An ability to adapt quickly to new computer technologies to meet business objectives
Excellent verbal and written communication skills, and superior knowledge and time management skills
Must demonstrate excellent collaboration, organization and teamwork skills
Bilingualism (English and French)
Experience in Drug Safety/Pharmacovigilance
Preferred is a professional with a background that includes communicating clinical and/or drug safety information in an organized health care setting
Receiving, acknowledging, assessing, following up, and entering data of adverse event reports from Spontaneous sources into the international safety database
Reporting of domestic adverse events (spontaneous and clinical) as appropriate to Health Canada
Receiving and reporting of foreign adverse events (spontaneous and clinical) to TPD/BGTD/MHPD and as per Health Canada regulations
Ensuring that adverse event reports are disseminated appropriately to internal staff
Proactively and reactively supporting teams who manage product related safety issues
Collaborating with other members of the Drug Safety team to implement process improvement strategies

Drug Safety Specialist Resume Examples & Samples

Daily screening of the Italian Health Authority (AIFA) PhV database (“Rete Nazionale di Farmacovigilanza”)
Receipt and follow-up of post-marketing adverse event reports occurred in the Italian territory and received from any possible source: e.g. fax machines, email systems and Italian Health Authority (AIFA) PhV databases (such as “Rete Nazionale di Farmacovigilanza”, and/or other databases that include safety data); alerting the Pharmacovigilance Manager of any new safety report
Receipt and follow-up of serious adverse events (SAE) occurred during investigational clinical trial
Safety reports check for consistency and accuracy , as well as appropriate translation of source documents if necessary
Filing, storage and archiving of safety-related documents
Prompt notification to the Pharmacovigilance Manager or IDSO staff of any potential safety issue
Assistance / direct execution of any needed administrative task for the IDSO
Degree in Life Sciences or Pharmacy, with good medical/scientific know-how
Good communication skills, including good written and spoken English
Good analytical skills and accuracy in daily work
Basic knowledge of Microsoft Office applications

Senior Drug Safety Specialist 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
Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists, including but not limited to: a) Assignment of resources and timelines; reorganization of daily workload based on priority b) Decision making for the project. c) Proactive communication to management new issues and suggested solutions; and reporting availability to take on new assignments. d) Development and review of project proposals, budgets, agreements, invoices, financial measures, and performance metrics. e) Preparation of a Safety Management Plan. f) Coordination of workload /workflow and coordination of status reviews. g) Review of project performance metrics (including quality parameters, monthly budget reports, and changes in scope). h) Approval of invoices
Manages systems for receipt and tracking adverse event (AE)/endpoint information
Processes AEs/endpoints according to Standard Operating Procedures (SOPs), and project specific safety plan. a) Triages AEs; evaluates AE data for completeness, accuracy and regulatory reportability. b) Enters data into safety /adjudication database. c) Performs Quality Control (QC) of entered data/endpoint dossiers. d) Codes events, medical history, concomitant medications,and tests. e) Compiles complete narrative summaries. f) Discerns what information requires querying and interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved. g) Participates in generation of reports to the sponsor and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. h) Assembles adjudication dossiers. i) Coordinates with data management staff reconciliation of safety data between the clinical and safety databases

Drug Safety Specialist Resume Examples & Samples

Execute receipt of Drug Safety phone calls and complete telephone AE form
Create phone call communication logs in ARISg
Execute QC on key fields of serious cases
Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
Create case narratives
Support the identification of corrections and creation of updates in ARISg following medical review
Update AE reports within safety database to support line listings
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

Drug Safety Specialist Resume Examples & Samples

Developing professional expertise, applies company policies and procedures to conduct complete clinical reviews of all domestic and foreign adverse event reports received for all FMCRTG,LLC
Ensures consistency in the initial evaluation and assessment of adverse event reports from all source documentation for completeness, accuracy and legibility for valid case entry into Safety Database and succinctly summarizing case narrative
Exercises judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, and listedness as per assigned product
Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet, Important Medical Terms Sheet
Produces Clinical Safety Queries as needed for clarification for reported events
Serves as a PV Safety contact to other departments and FMCRTG,LLC licensing partners
Interacts on a regular basis with Clinical Project Manager, Case Processing Manager, Medical Affairs, Quality, Regulatory Affairs, etc. to identify process improvement strategies and communicate Pharmacovigilance related project and Activity status updates
Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc.) to resolve safety-related issues
Performs quality related activities related to Field Alert Reporting, and CAPA as assigned
Performs various assigned activities by the PV department leadership
Normally receives general work instructions on routine work, detailed instructions on new projects or assignments.Work is reviewed for soundness
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.Exercises judgment within defined procedures and practices to determine appropriate action
Assists with various projects as assigned by direct supervisor
2 – 5 years of drug safety experience in a biotechnology, and/or pharmaceutical company
Working knowledge of ICH/GCP guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries
Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development
Knowledge of GXP Scope (Good Pharmacovigilance Practice)
Demonstrated Good Documentation Practices
Must be proficient in MS Office Suite, Argus, ArisG Safety system(s)

Drug Safety Specialist Resume Examples & Samples

Conduct the assessment of all individual adverse event case reports
Experience: Two (2) years of clinical experience
Knowledge: Computer and database skills preferred
Competencies: Excellent writing skills, organization and planning, attention to detail, data management, time management, team work, strong communication skills

Medical Information & Drug Safety Specialist Resume Examples & Samples

Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners, regarding marketed products, investigational compounds, clinical trials and other product information
Contribute to the development and revision of standard medical responses, Q & A documents, and other medical information resources
Entering information for medical information enquiries into medical information databases, tracking systems and project-specific forms ensuring accurate data-entry
Maintaining a library of responses to Frequently Asked Questions and of Standard Response Letters
Identifying Individual Case Safety Reports and technical product complaints and forwarding them to the relevant stakeholders within pre-determined timelines
Process individual Case Safety Reports (ICSRs), including data entry in the electronic database
Prioritize cases by seriousness and outcome and assign Follow up time points on all reports as required
Create Annual Summary Reports in compliance with Health Canada regulations, review as per calendar and follow up with business partners for compliance as needed
Perform reconciliation of safety databases, safety tracking systems, medical information databases, product complaint databases and clinical databases
Perform Canada vigilance Screening
Perform the literature search and signal detection
Participate in continuous improvement projects
Participate as an active member of multidisciplinary teams to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors
Mentor less-experienced team members
Assist with regulatory agency inspections, client audits and internal audits
Other duties as determined
Good knowledge with medical terminology (e.g. MedDRA and WHODRUG)
Excellent scientific and clinical knowledge
Customer-focused, detail-oriented organized and flexible
Excellent quality planning and organization of work
Exceptional communications experience including written, verbal, and presentation skills
Proven ability in the implementation of new initiatives and receptive to change in demands and workload
Proficient computer literacy including PV database systems
Fully Bilingual (French and English), oral and written

Senior Drug Safety Specialist Resume Examples & Samples

Perform case processing activities including triage, data entry, adverse event extraction and ranking, selecting or verifying the appropriate coding (using MedDRA and the WHODrug Dictionary), narrative preparation, and case submissions
Perform initial case assessment for seriousness and expectedness/labeling based on medical context and regulatory requirements
Perform initial assessment to determine if the case meets criteria for adverse event of special interest (AESI)
Review source documents and ICSR information in order to verify accuracy, completeness and consistency. Perform Quality Control on cases processed by other team members
Generate follow-up requests and contact reporters as appropriate to obtain missing case information and/or additional clarifications. Ensure that all required follow-up attempts for assigned cases have been completed. Track and document all queries
Determine and/or confirm if the case meets expedited reporting criteria. Ensure adverse event reporting compliance with AMAG SOP’s, SDEA timeframes, FDA, EMA, ICH and other regulatory requirements
Maintain working knowledge of regulatory requirements, guidance documents, SOPs, work instructions and other internal documents as related to ICSR processing and evaluations
Works collaboratively with pharmacovigilance physicians on ad-hoc data reviews as needed
Assist with preparing and/or reviewing ICSRs or safety summaries for aggregate safety reports (DSUR, PADERs, PSURs,) as needed or requested
Assists with the development and/or updates of SOPs, Work Instructions, forms, conventions or other internal documents as needed
Pharm D, Bachelor’s degree in pharmacy, nursing, life sciences or equivalent. Master’s or other advanced degree in life sciences is a plus
Minimum 3 years of experience in pharmacovigilance/drug safety
Working knowledge of drug safety databases (Argus or Arisg) is required
Working knowledge of MedDRA and WhoDrug coding principles and practical applications
Knowledge of guidance documents and regulatory requirements as applied to clinical trial and post-marketing adverse event reporting
Demonstrated ability to set priorities, work independently and collaboratively
Demonstrated ability to apply clinical judgment and clearly communicate complex issues
Strong organizational skills and demonstrated ability to focus on quality with attention to details
Proficiency in the use of Windows and MS Office applications and ability to learn new systems as needed

Senior Drug Safety Specialist Resume Examples & Samples

Conduct the assessment of all serious individual adverse event case reports stemming from pre-/clinical studies, post-marketed and literature sources
Education: Minimum of B.S. or the equivalent combination of relevant education or professional experience. Current registered medical license preferred
Experience: Two (2) years of clinical experience; RN or PharmD preferred
Experience: Two (2) years of drug safety experience at a minimum
Knowledge: Clinical knowledge of therapeutic area, patient populations and drug class
Knowledge: Proficient computer skills and safety database experience preferred
Competencies: Decision making, excellent writing skills, organization and planning, attention to detail, data management, time management, leadership skills, team work, strong communication skills

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