Role OverviewLead safety activities and benefit-risk strategies for assigned BMS compounds/program and chair the product Safety Management Team(s). Oversee, prepare and/or review aggregate safety review documents and safety sections of relevant clinical trial documents and regulatory filings.
What You Will Do
Lead team in the evaluation & management of safety signals emerging from any data source. Develop strategy for signal evaluation and document outcome. Lead safety labeling activities for assigned products.
Why It Might Be a Fit
Provide input to R&D publication strategy/plan & ensure safety input to publications/presentations. Actively drive safety strategy preparation and Represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
Requirements
- MD or DO degree
- Board certification in a medical specialty
- Pharmaceutical industry experience
- Clinical research experience
- Leadership experience
Benefits
- Competitive salary
- Benefits package
- Equity
- 401(k) plan
- Health insurance
- Paid time off
- Professional development opportunities
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