About This Role
As PV Scientist, you are responsible for assigned tasks for designated products or product groups. You will report to a Sr. PV Scientist or above, you will serve either as a lead PV Scientist or supporting PV Scientist, depending on the assigned product or product groups. Irrespective, you will be a critical team member whose responsibilities include 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.
In this role, with oversight from your manager, you will serve as a Subject Matter Expert for the Global Safety and cross-functional team on relevant global safety regulations and guidelines, data output and analyses, and product information.
What You’ll Do
- Collaborate 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).
- Facilitate signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Global Safety Officer, Safety physicians and Sr. PV Scientist / AD, perform routine signaling activities including evaluation of safety data for new 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, collaborate 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, coordinate and author responses to safety questions from regulatory authorities for assigned products.
- Contribute to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Who You Are
You are a passionate, resourceful and motivated PV Scientist with strong problem-solving capabilities who brings enthusiasm to the role.
- 5+ years Pharmaceutical industry experience, with a minimum of 3 years of PV experience
- Bachelor’s Degree in biologic or natural science; or healthcare discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred
- 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.
- 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, 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.
- 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.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.