Senior Manager / Drug Safety Senior Manager
A globally renowned Biotechnology corporation located in Cambridge, Massachusetts is seeking to hire a Drug Safety Senior Manager for a 6-month contract opportunity. This individual will serve as a product lead for Pharmacovigilance activities within the SABR Medical function
The Drug Safety Senior Manager will be responsible for: 1) collaborating with Global Safety Officers and other SABR 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. 2) Leads process for responding to safety questions from regulatory authorities. 3) Leading initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions. 4) Leading and collaborating with Aggregate Reports on 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).
Duration: 6-month contract
Compensation: $75-80 per hour
- Education: 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 is required.
- Strong background in clinical trial drug safety is required
- Must understand, interpret, analyze, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
Sthree US is acting as an Employment Business in relation to this vacancy.