The Pharmacovigilance (PV) Scientist is responsible for product lead for PV within the Safety Medical team. As a PV Scientist, you will help oversee and lead the process safety signal management, aggregating reports responding to safety questions from stakeholders, reviewing medical and scientific literature for safety information, as well as supporting Clinical Trial PV medical processes. In addition, the PV Scientist will serve as the Subject Matter Expert for Global Safety.
- Coordinating the signal management processes for the assigned product(s) and evaluating the safety data and signals of PV activities.
- Provide functional and therapeutic area expertise, supporting less experienced colleages and the safety effort more generally.
- Collaborating with the Global Safety Officers and other Safety MDs for investigational programs including clinical trial processes, safety committee management, data analysis, signal detection, ad hoc requests and other product activities.
- Responsible for compiling the Aggregate Reports on strategy for the assigned products (PSURs, DSURs, PV Plans, Risk Evaluation and Mitigation Strategy Plans, Risk Management Plans, etc.)
- 3-6 Years of Pharmacovigilance experience, with a strong familiarity in aggregate safety reports and safety signal management.
- Strong PV and drug development foundation with knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
- Conducts, independently and collaboratively, each aspect of substantive projects (signalling, authoring aggregate data reports, response to regulatory agency requests, etc.)
- Bachelor's Degree in natural or biologic science; or health case discipline
- Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred, or extensive PV experience.
Sthree US is acting as an Employment Business in relation to this vacancy.