The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.
Primary Responsibilities
- Leading the signal management process for assigned product(s) and evaluating safety data and signals as part of ongoing pharmacovigilance activities.
- Leading signaling review process and Safety Signaling Team meetings
- Managing literature review for safety information
- Collaborating with Global Safety Officers and other Safety MDs for assigned investigational programs
- Leading process for responding to safety questions from regulatory authorities
- Contributing to initiatives for process improvement and consistency
- Leading Aggregate Report management, including 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).
Qualifications
- 5 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- Bachelor's Degree in biologic or natural science; or health care discipline
- Advanced degree (PhD, MPH, PharmD, etc.) required
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format
- Demonstrates leadership and interacts collaboratively and effectively in a team environment
- 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
- Applies 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
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects)
