At Biogen, we jointly ensure that patients are supplied with medicines that make a difference in their lives every day.
SENIOR PHARMACOVIGILANCE SCIENTIST
- Badhoevedorp, Netherlands
- Department: Research & Development
- Region: EU+/Canada
We offer an exciting role were you will be an integral part of our Biogen team. You will as Senior Pharmacovigilance Scientist serve as a product lead for Pharmacovigilance activities within the Safety function.
The Senior PV Scientist team 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. The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.
- Leads the signal management process (i.e., signal detection, tracking, leading review meetings) 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 Safety 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 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).
- Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required.
- 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 (including intermediate understanding and application of medical concepts and terminology).
- 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 PV Scientist staff.
- 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. Includes knowledge of case processing, expedited reporting rules, and safety database concepts
- Strong organizational skills, including the ability to prioritize independently with minimal supervision
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects)