Pharmacovigilance Scientist Resume Samples

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S Pouros

Sofia

Pouros

942 Kaden Ports

San Francisco

+1 (555) 341 2822

942 Kaden Ports

San Francisco

Phone

p +1 (555) 341 2822

Experience Experience

Detroit, MI

Pharmacovigilance Scientist

Detroit, MI

Olson-Mitchell

Detroit, MI

Pharmacovigilance Scientist

Perform aggregate safety analysis and case level review
Represents PS on cross-functional project teams for developmental compounds and/or marketed products
Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products
Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports
Perform literature searches and identify/analyze relevant publications
Providing input into periodic reports (PSUR, BR, AR, ASR, DSUR)
Develop report strategy with stakeholders

Detroit, MI

Senior Pharmacovigilance Scientist

Detroit, MI

Auer, Klocko and Lubowitz

Detroit, MI

Senior Pharmacovigilance Scientist

Provide safety content review of clinical protocols, CSRs, and ICFs
Support development and/or maintenance of core and local label for Kite products (e.g., CDS, USPI, SmPC, IB, etc)
Contribute to development of signal detection strategy for post marketed products
Support signal detection, evaluation and management according to Kite SOPs and guidelines
Support preparation and maintenance of Risk Management plans
Represents SABR and/or Pharmacovigilance on study teams, cross function product teams, etc
This role can be based in Cambridge, Mass or Maidenhead, UK

present

Philadelphia, PA

Principal Pharmacovigilance Scientist

Philadelphia, PA

Schroeder-Blanda

present

Philadelphia, PA

Principal Pharmacovigilance Scientist

present

Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products
Provides subject matter expertise in the therapeutic area and across multiple products
Leads safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts
Leads negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements
As a Safety expert leads presentation of complex issues to Safety Information Review Committee (SIRC)
Leads safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines
Work with PV team on continuous process improvements in the field of safety surveillance, SOPs, guidance documents, templates, tools, upgrades

Education Education

Bachelor’s Degree in Life Sciences

University of San Francisco

Bachelor’s Degree in Life Sciences

Skills Skills

Drives Accountability (creates cross-boundary accountability)
Utilize technical skills and programs to analyze and organize data (eg, Excel pivot tables, SAS JMP)
Partner with vendor to develop safety supporting documents/deliverables
Perform aggregate safety analysis and case level review
Works Collaboratively (establishes shared purpose across boundaries)
Develops People and Organisation (invests in long-term development of others)
Develop report strategy with stakeholders
Initiate/conduct searches of internal and external databases
Commitment to Customers and Integrity (represents and shapes customer perspectives)
Perform literature searches and identify/analyze relevant publications

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Pharmacovigilance Scientist Lead Resume Examples & Samples

30% Product management/oversight. Oversight and assumes responsibility for assigned therapeutic products and PV activities. Supports an organizational structure that meets the evolving needs of Shire and the PVRM department. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the PV Scientist Team Lead, Therapeutic Area Head, Head of Shire Pharmacovigilance and Risk Management and the Qualified Persons for Pharmacovigilance, including the EU QPPV
30% Aggregate report production. Responsible for the production of periodic and ad-hoc safety reporting for therapeutic team products, where Shire is the Global Safety Database holder. Establishes project management responsibility for aggregate reports (e.g. PBRER, DSUR, topic reports) within the therapeutic team to ensure effective planning such that stakeholder input is requested/received for applicable sections of the report and regulatory timelines are met. Collaborates with the PV physicians to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and utilizes Shire’s EDMS system to provide quality control
20% Safety Review Team Coordination and signal detection. Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Shire products. Responsible for efficiently planning routine and ad-hoc Safety Review Team (SRT) meetings and ensuring that stakeholders provide input from their respective areas of responsibility. Ensures that regulatory commitments and risks described in the product Risk Tracking Document are efficiently tracked and presented as part of the SRT process. Works with SRT Co-chairs to facilitate communication and support for decisions resulting from the SRT. (e.g. update of RMPs, labeling, regulatory notifications)
20% Support for investigational products and registration activities. Effectively collaborate with stakeholders outside of PVRM. Represent PVRM department in cross-functional clinical programs and registration activities and provide PVRM support for clinical developmental programs
Life Science Degree or Healthcare Professional
Experience in a pharmaceutical company (5+ years preferred) preparing, writing, authoring and submitting periodic safety reports

Pharmacovigilance Scientist Development Team Lead Resume Examples & Samples

30% - Product Management/Oversight. May act as a functional line manager to PV Scientists or a manager for a product or group of products. Oversight and assumes responsibility for assigned therapeutic products and PV activities. Supports an organizational structure that meets the evolving needs of Shire and the PVRM department. May be responsible to manage the development, objective setting and performance assessment of direct reports. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the PV Scientist Team Lead, Therapeutic Area Head, Head of Shire Pharmacovigilance and Risk Management and the Qualified Persons for Pharmacovigilance, including the EU QPPV
20% - Development Aggregate Report Production.Responsible for the production of aggregate and ad-hoc safety reporting for therapeutic team products, where Shire is the Global Safety Database holder. Establishes project management responsibility for development aggregate reports (e.g. DSUR, topic reports) within the therapeutic team to ensure effective planning such that stakeholder input is requested/received for applicable sections of the report and regulatory timelines are met. Collaborates with the PV physicians to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and utilizes Shire’s EDMS system to provide quality control
20% - Safety Review Team Coordination and Signal Detection. Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Shire products. Responsible for efficiently planning routine and ad-hoc Safety Review Team (SRT) meetings and ensuring that stakeholders provide input from their respective areas of responsibility. Ensures that regulatory commitments and risks described in the product Risk Tracking Document are efficiently tracked and presented as part of the SRT process. Works with SRT Co-chairs to facilitate communication and support for decisions resulting from the SRT. (e.g. update of RMPs, labeling, regulatory notifications)
20% - Support for Investigational Products and Registration Activities. Effectively collaborate with stakeholders outside of PVRM. Represent PVRM department in cross-functional clinical programs and registration activities and provide PVRM support for clinical developmental programs
10% - Alliance Management for Outsourced PV Work. Provide guidance and oversight for CROs performing activities related to clinical trial SAEs

Pharmacovigilance Scientist Resume Examples & Samples

Lead cross-functional Medical Surveillance Teams (MSTs) and assigned subteams, such as Clinical Data Review (CDR) Teams, and participate in related PV and product-development subteam(s). Appropriately elevate issues impacting key MST activities, milestones, documents to the MST Chair. Mentor individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs
Create MST/assigned subteam meeting agendas and documentation of decisions, conclusions, timelines, milestones and action items in team minutes. Consistently ensures scientist verification of completion of action items to ensure that appropriate data, strategy, project milestones and individual member responsibilities are addressed and fully communicated. Influence the assigned team(s)
Periodic review and summary of pertinent safety-related literature, analysis of pre-determined core signal data. Provides advice and mentoring to scientists of summaries, evaluations and conclusions
Collaborate within and across client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required
Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings
Coordinate and integrate scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to ad hoc queries and HA commitments. Contributing to and authoring regulatory documents

Principal Pharmacovigilance Scientist Resume Examples & Samples

Lead Global DS&E initiatives to develop business solutions and meet emerging regulatory requirements, by directing cross-functional teams, managing progress, quality and timely completion of deliverables, and reporting progress to DS&E leadership
Author along with Global Medical Safety Physicians, key regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for newly launched Novartis products: leading cross-functional expert team and collecting, organizing, analyzing and presenting the data by means of DS&E templates and proce-dures
Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing)
Develop procedures to monitor Central DS&E and CPO compliance to regulatory requirements
Drive the quality review/sampling of ICSRs and literature as part of DS&E quality management system
Review global marketing programs and establish process for AEs collection with global marketing teams as required
Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of pharmacovigilance commitments as required
Proactively collaborate with licensing partners and Clinical Research Organizations to meet joint accountabil-ties
Collaborate with Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database
Co-lead Safety Profiling Teams for newly launched products to ensure that case reports are accurately evalu-ated and databased, and authoring Product Specific Guidelines for assigned products
Lead the preparation of Standard Operating Procedures and Argus processing conventions
Develop and test safety systems/IT applications as business lead/co-lead and support the preparation of rele-vant manuals
Lead sessions during Health Authorities inspections and audits as Subject Matter Expert, and lead the development and implementation of Corrective and Preventative Actions (CAPA) to address safety findings
Act as Subject Matter Expert in cross-functional projects and external meetings
Deputize for Team Leader/Group Head and assist with the recruitment of new staff
Drive continuous DS&E business improvements by initiating & managing initiatives
Number, timeliness and quality of deliverables according to established directives
Role model of company values & behavior

Senior Pharmacovigilance Scientist 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**
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 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
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems

Pharmacovigilance Scientist Resume Examples & Samples

Accountable for efficient and accurate maintenance and monitoring of data and processes to support the management of individual case safety reports
Responsible for developing and maintaining up to date knowledge for assigned drug responsibilities, regulatory authority regulations and internal processes and procedures. To use said knowledge to provide input to topics as a Subject Matter Expert and to advise members of PDS/other departments on safety and pharmacovigilance related topics as needed
Responsible for supporting ICSR Team Manager and Senior PV Scientists with improvements and /or remediation’s to processes and procedures as applicable
Responsible for training and mentoring team members on the team deliverables to effectively deliver high quality, compliant and medically cohesive ICSRs
Responsible for engaging with Stakeholders within and outside PDS, to develop better working relationships, move forward with prioritised process improvements and ensure smooth, well defined handoffs
Ensuring readiness for Audits & Inspections
Supporting/leading process improvement and simplification activities following continuous improvement principals across the department by collaborating with stakeholders and other teams within PDSO to provide expertise and input into ICSR-M related areas, as well as effective CAPA development and management

Senior Pharmacovigilance Scientist Resume Examples & Samples

Lead Pharmacovigilance projects to develop business solutions and meet regulatory requirements, by directing the team, manage progress, quality and timely completion of deliverables, and reporting progress to DS&E management
Author along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for Novartis in-patent products: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures
Review emerging regulatory guidelines and legislations and identification of impact to DS&E processes
Collaborate with licensing partners and Clinical Research Organizations to meet joint accountabilities
Review global marketing programs and establish process for AEs collection with global marketing teams
Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments
Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents
Key contributor to Safety Profiling Teams to ensure that case reports are accurately evaluated and database, and authoring Product Specific Guidelines for assigned products
Contribute to the preparation of Standard Operating Procedures
Participate in Health Authorities inspections and audits as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings
Act as Subject Matter Expert in cross-functional meetings
Train and mentor new DS&E associates and associates from other line functions
Ability to lead cross-functional teams

Pharmacovigilance Scientist Resume Examples & Samples

Alert manager to potential safety signals based on incoming case reports
Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and database
Assist with related administrative and procedural activities as required or requested
Assists in the training of other Safety Processing Experts as necessary
Support DS&E Projects or database validation activities as required

Pharmacovigilance Scientist Resume Examples & Samples

Collaborate with Electronic Data Management team to reconcile Serious Adverse Events be- tween the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database
Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products
Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products
Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP)
Support the development and testing of safety systems/IT applications and in the preparation of relevant manuals
Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings
Train and mentor new DS&E associates
Ability to learn quickly
Consistent demonstration of company values & behavior

Principal Pharmacovigilance Scientist Resume Examples & Samples

Collaborate with the Medical Safety Physicians and other line functions to monitor the safety profile of newly launched products, by analyzing large data sets, reviewing clinical study protocols, responding to inquiries from Health Authorities, drafting communications to Health Care Professionals, and responding to CPO requests
Author along with Global Medical Safety Physicians, key regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for newly launched Novartis products: leading cross-functional expert team and collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures
Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments as required
Proactively collaborate with licensing partners and Clinical Research Organizations to meet joint accountabilities
Co-lead Safety Profiling Teams for newly launched products to ensure that case reports are accurately evaluated and database, and authoring Product Specific Guidelines for assigned products
Lead the preparation of Standard Operating Procedures
Develop and test safety systems/IT applications as business lead/co-lead and support the preparation of relevant manuals
Train and mentor new associates
Assist with the recruitment of new staff
Ability to lead cross-functional teams and represent DS&E at external meetings

Pharmacovigilance Scientist Resume Examples & Samples

Supports the process for preparing and authoring aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs). Interacts with vendor contracted to author such reports for specific products, as needed
Assists with signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with SABR MDs and Sr. PV Scientist / AD, evaluates safety data and signals as part of ongoing pharmacovigilance activities. May include authoring signal evaluation reports, or sections of signal evaluation reports. May include support of literature review for safety information
With Sr. PV Scientist / AD oversight, supports Clinical Trial Physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned
In collaboration with Sr. PV Scientist / AD, 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, clinical trial safety oversight, signal management and responding to ad hoc safety questions
Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology)
Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Applies clinical judgment to interpret case information

Pharmacovigilance Scientist Resume Examples & Samples

Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate
Represents PS on cross-functional project teams for developmental compounds and/or marketed products
Has the ability to present safety information at external meetings
Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects
Presents issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders
Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
Collaborates with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion
Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients
Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines
Authors/provides strategic input to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts
Contributes to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement
Trains junior members of the team in PS tools and systems
Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate
Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products
Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports
Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects
Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders
Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products
Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines
Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts
Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements
Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc
A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience. This should include aggregate reporting, safety surveillance and analytics
Intermediate (PV Sci) to advanced (Sr PV Sci) knowledge of PV regulations
Fluent in written and verbal English
MD, MSc/PhD in scientific discipline, preferred
Basic (PV Sci) to intermediate (Sr PV Sci) understanding of epidemiology data, preferred

Principal Pharmacovigilance Scientist Resume Examples & Samples

Leads the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate
Provides subject matter expertise in the therapeutic area and across multiple products
Has the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization
Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products
As a Safety expert leads presentation of complex issues to Safety Information Review Committee (SIRC)
Leads safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines
Leads safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts
Leads negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements
Takes accountability and leads resolution of complex safety issues and mediates cross-functional agreement
Has the ability to participate in due diligence activities

Pharmacovigilance Scientist Resume Examples & Samples

Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased
Triage literature cases for databasing or pass them on to the Team Leader for approval of rejection
Co-author, together with the Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data
Work with external partner groups, e.g. co-licensing partners and Clinical Research Organisations to meet joint accountabilities
Represent DS&E at internal and external meetings
Assist the Medical Safety Physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports
Assist the Medical Safety Physicians in monitoring the safety profile of product 8. Be involved in development and testing of safety systems/IT applications and in the preparation of relevant manuals
Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs Impact on the organization
13 Ensure that Serious Adverse Event / Post Marketing Adverse Event are evaluated accurately and within the required timeframes to meet regulatory requirements
Alert the Medical Safety Physicians to potential safety issues

Pharmacovigilance Scientist Resume Examples & Samples

Good knowledge of pharmacovigilance practices
Good knowledge of US and EU pharmacovigilance regulatory requirements
Ability to present and critically discuss safety data in both internal and external discussions
Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
Team player with ability to function in a cross-functional environment
Self–motivated, able to prioritize and plan effectively, and independently, with minimal supervision
Fluent in English (verbal and written)
Good moderator skills
Ability to navigate in databases and pull information correctly
Good organizational skills and attention to detail

Pharmacovigilance Scientist Resume Examples & Samples

Evaluation of safety data for assigned products
Interpretation of reviewed data
Drafting of reports and writing and/or review of key documents in the context of safety andbenefit risk for assigned products (RMP, Health Hazard Evaluation, IB, NDA submissions, adhoc expert reports, supporting documents for the assignment of frequency categories toADRs)
Overview of key safety information and draft summary of documents supporting responsesto Health Authorities and Affilitate queries, Ethics committees, revision of company coresafety data sheets; drafting of (sections of) and/or assisting GSO with Clinical Overviews,Summary of Clinical Safety, Investigator’s Brochures, etc
Initiating and reviewing searches of safety data in respective databases
Providing input into periodic reports (PSUR, BR, AR, ASR, DSUR)
Acquire and maintain therapeutic area knowledge and ongoing assessment of therapeutic areas, competitive products and therapies

Pharmacovigilance Scientist Resume Examples & Samples

4 Work with external partner groups, e.g. co-licensing partners and Clinical Research Organisations to meet joint accountabilities
Assist the Medical Safety Physicians in monitoring the safety profile of product
Be involved in development and testing of safety systems/IT applications and in the preparation of relevant manuals
Ensure that Serious Adverse Event / Post Marketing Adverse Event are evaluated accurately and within the required timeframes to meet regulatory requirements

Pharmacovigilance Scientist Resume Examples & Samples

Explore complex safety data from clinical studies and post-marketing sources and present at internal, external and professional meetings
Signal detection and evaluation in collaboration with the Safety Physicians
Monitor identified areas of interest – produce dashboards
Prepare, compile, author, or collaborate in various aggregate reports such as PADERs, annual IND reports, PSURs/PBRERs, DSUR, Clinical Overviews, Safety Summaries
Work with PV team on continuous process improvements in the field of safety surveillance, SOPs, guidance documents, templates, tools, upgrades
Represent DS PV in functional project teams, with business partners and CROs
Perform periodic scientific literature review for safety content
Minimum BS or Health Care Professional (RN, BSN, PA, etc.)
5 years relevant experience in PV and risk management
Experience in all safety regulatory document types (e.g., IND annual report, ASR, DSUR, PSUR, PADER, EU RMP, ISS, and ad hoc safety responses for Regulatory Authorities)
Knowledge of FDA, EU, and ICH guidelines and regulations
Proficiency with Safety database management and design
Knowledge of clinical trials and drug development
Coding dictionaries (e.g., WHO ATC drug dictionary, and MedDRA)
Advanced Bioscience degree (MS, PhD, Pharm D, MD, …)
Preferred Experience with quantitative methods is a plus
Experience in project management are desired
Safety database management and design in Argus
Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Project, Visio and Adobe Acrobat
Familiarity with analytics tools (e.g. Cognos, Spotfire, etc.)
Excellent oral communication
Excellent writing skills
Planning, coordination, and organizing
Decision making, judgment, and problem solving
People skills, influencing skills
Attention to detail combined with the ability to summarize
Work well in team
Ability to work in tight timelines while maintaining accuracy
Ability to work proactively with minimal supervision

Principal Pharmacovigilance Scientist Resume Examples & Samples

Appropriately experienced to undertake all usual Pharmacovigilance Scientist activities, including case report QC, review, follow-up reportability assessments and input into aggregate safety reports globally, with the flexibility of mindset this requires
Work with other relevant functional areas both within and outside of global PV to ensure efficient and timely attainment of compliant and patient focused safety data
Represent pharmacovigilance department in cross-functional teams and/or meetings at a regional and global level as required, alongside the commensurate communication skills required
Build on knowledge and understanding of designated products/studies
Regular interaction with scientist and physician colleagues under the auspices of the safety Therapeutic Area Lead (TAL), particularly when the responsible GSL
Help mentor new entrants/less experienced PV scientist colleagues
Appropriate involvement in ongoing professional education/training to ensure contemporary skill set
Involvement in facilitating safety procedures for developmental programs
Bachelors required; Advanced degree in scientific/medical field preferred
Detailed knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis
Critical thinking and decision making skills
Commitment to a global organization
Excellent communication and presentational skills

Principal Pharmacovigilance Scientist Resume Examples & Samples

Collaborate with the Medical Safety Physicians and other line functions to monitor the safety profile of newly launched products, by analyzing large data sets, reviewing clinical study protocols, responding to inquiries from Health Authorities, drafting communications to Health Care Professionals, and responding to CPO requests. -Lead Global DS&E initiatives to develop business solutions and meet emerging regulatory requirements, by directing cross-functional teams, managing progress, quality and timely completion of deliverables, and reporting progress to DS&E leadership. -Develop procedures to monitor Central DS&E and CPO compliance to regulatory requirements. -Drive the quality review/sampling of ICSRs and literature as part of DS&E quality management system. -Review global marketing programs and establish process for AEs collection with global marketing teams as required. -Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of pharmacovigilance commitments as required. -Proactively collaborate with licensing partners and Clinical Research Organizations to meet joint accountabil-ties. -Collaborate with Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database. -Co-lead Safety Profiling Teams for newly launched products to ensure that case reports are accurately evalu-ated and databased, and authoring Product Specific Guidelines for assigned products. -Lead the preparation of Standard Operating Procedures and Argus processing conventions. -Develop and test safety systems/IT applications as business lead/co-lead and support the preparation of rele-vant manuals. -Review emerging regulatory guidelines and legislations and identification of impact to DS&E processes. -Lead sessions during Health Authorities inspections and audits as Subject Matter Expert, and lead the development and implementation of Corrective and Preventative Actions (CAPA) to address safety findings. -Act as Subject Matter Expert in cross-functional projects and external meetings. -Train and mentor new DS&E associates and associates from other line functions. -Deputize for Team Leader/Group Head and assist with the recruitment of new staff
4 to 7 years experience in Drug Development or closely re- lated areas of responsibility, with a minimum of 3 to 5 years’ experience in drug safety
Excellent understanding of drug development process, GCP and medical terminology
Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions and sites
Strong organizational and project management skills
Ability to lead global and cross-functional work groups
Ability to mentor and coach

Pharmacovigilance Scientist Phd-research & Development Resume Examples & Samples

An advanced degree in either a health care profession (e.g. Pharm. D., M.D.) or life science (PhD)
Good collaboration skills and experience in establishing and maintaining working relationships
Excellent written and oral communication skills in English with an emphasis on communication of human health relevance, safety and clinical information. Experience with external communications to regulatory authorities and industry groups would be beneficial but is not essential
Excellent organization skills, an attention to detail and an ability to manage complex systems
Experience with databases, data reporting tools and statistical analysis would be beneficial

Senior Pharmacovigilance Scientist Resume Examples & Samples

Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information
Collaborates with Global Safety Officers and other SABR MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned
Leads process for responding to safety questions from regulatory authorities
Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions
Leads and collaborates with Aggregate Reports on strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs)
Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
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
Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts

Pharmacovigilance Scientist Resume Examples & Samples

Participate in cross-functional Medical Surveillance Teams (MSTs) and assigned subteams, such as Safety Data Review (SDR) Teams, and participate in related PV and product-development subteam(s). Appropriately elevate issues impacting key MST activities, milestones, documents to the MST Chair
Periodic review of pertinent safety-related literature, analysis of pre-determined core signal data. Provides advice and summaries, evaluations and conclusions of safety data reviewed
Collaborate within and across client's functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required

Senior Pharmacovigilance Scientist Resume Examples & Samples

Assist in oversight of Pv vendors/CROs as applicable
Contribute to preparing safety assessments reports
Participate in preparing responses to safety related requests from health authorities
Previous experience in preparing periodic safety reports and risk management plans
Demonstrated persuasion, influencing and negotiation skills
Effective team player, with proven ability to effectively lead projects and teams to successful conclusion

Pharmacovigilance Scientist Resume Examples & Samples

Develop report strategy with stakeholders
Initiate/conduct searches of internal and external databases
Perform aggregate safety analysis and case level review
Perform literature searches and identify/analyze relevant publications
Present results to safety physician or cross-functional team
Author/contribute to the preparation of safety supporting documents
Partner with vendor to develop safety supporting documents/deliverables
Comply with processes and ensure appropriate documentation
Utilize technical skills and programs to analyze and organize data (eg, Excel pivot tables, SAS JMP)
Adhere to report timelines and escalate issues to management as appropriate
Bachelor’s degree in health or biomedical science (6+ years industry experience or equivalent) or
Advanced degree preferred in health or biomedical science (4+ years industry experience or equivalent)
Clinical/medical writing and/or PV experience
Aggregate safety report writing and aggregate safety analysis
Knowledge of MedDRA hierarchy
Searching and analysis of the literature

Pharmacovigilance Scientist Resume Examples & Samples

Responsible in leading scientific, technical or drug safety input for a project, group of products, systems or processes across the CDS Regions
You will represent the Region, externally where required. You may lead a group of Clinical Drug Safety colleagues to deliver a project and project manage across a number of groups and/or projects and use in depth knowledge of specific products, therapeutic or technical areas. Senior Patient Safety Scientists are also mapped to this job capsule
As a Pharmacovigilance Scientist you will participate in the triage process for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information
Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
Responsible to review adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
Lead teams in preparing, organizing, and reviewing tabulations for Regulatory reports. You assume responsibility for completing special projects (i.e. IND Annual Reports, PSUR table preparation)
Support Safety Surveillance, Safety Support - Compliance and Marketing Company and the US Clinical Teams
Serve as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues
Responsible for reflecting the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
Initiate special projects and demonstrate leadership capabilities at target level or above
Personal responsibility for creating a culture of courageous leadership, creativity and collaboration