Pharmacovigilance Scientist

Essential Duties

• Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
• Coordinate and document ongoing safety surveillance activities. Activities will include safety data review, signal validations, signal evaluations, literature reviews
• Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks
• Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities
• Cover responses for ad hoc safety queries (eg, health authority requests) in collaboration with the cross functional team members, as needed
• Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization
• Represent safety at cross functional product meetings
• For investigational product(s): Support activities relevant to investigational program including (but not limited to): Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFs, Ongoing data review, including lab, vitals, ECG, and AE data review, Review preliminary data and prepare presentations for safety review committees

Necessary Skills and Abilities

• Demonstrated experience in analysis 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
• Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed
• 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
• Scientifically sound and clinically accurate approaches to interpret data involving patient safety
• 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 knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System