The PV Scientist will serve as a critical team member with the lead PV Scientist (Sr. PV Scientist or Associate Director) for products or product groups, including performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring responding to ad hoc regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams.
The PV Scientists are responsible for assigned tasks for designated products or product groups. With oversight from your manager, will serve as a Subject Matter Expert for the Safety and cross-functional team on relevant global safety regulations and guidelines; data output and analyses; and, product information.
- Collaborates on the preparation and authoring 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).
- Facilitates signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with Safety 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.
- Conducts literature review for safety information and interacts with other groups to obtain necessary data (i.e., Epidemiology, SAE data).
- With Sr. PV Scientist / AD oversight, collaborates with 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, coordinates and authors 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.
- Minimum 5 years industry experience, with a minimum of 3 years of PV experience.
- 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
- 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.
- Applies clinical judgment to interpret case information.
- 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 organizational skills, including the ability to prioritize independently with minimal supervision.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
- Bachelor’s Degree in biologic or natural science; or health care discipline
- Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred