Senior PV Scientist
- Badhoevedorp, Netherlands
- Department: Research & Development
- Region: EU+/Canada
Joining us as Senior PV Scientist, you will serve as a product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), 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, along with the Associate Director is responsible for hiring, training, mentoring and managing staff within their assigned products. 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. In this capacity, the Sr. PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.
- Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, 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.
- Leads process for responding to safety questions from regulatory authorities.
- 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).
- 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
- Bachelor’s Degree in biologic or natural science; or health case discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred
- Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management
- 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
- 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).
- 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
- 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
- Applies clinical judgment to interpret case information
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.