Role Overview
The Pharmacovigilance and Risk Management (PVRM) Senior Medical Director will be responsible for the medical safety aspects of clinical trials, including review and assessment of individual case safety reports, and providing medical safety subject matter expertise in the review and approval of documents.
What You Will Do
Lead safety strategy and key messaging in NDA/BLA/MAA submissions, provide PVRM Medical representation on product specific and/or clinical study team meetings and governance committees, and prepare and present safety data analysis to project teams and senior management.
Why It Might Be a Fit
This role requires a thorough knowledge of the pharma industry, especially clinical research and global regulatory requirements, and experience managing expedited and periodic safety reporting, signal generation, safety evaluation and risk management strategies.
Requirements
- Medical Degree (MD) with 12 + years of relevant experience in biotech or pharmaceutical industry
- Experience in Oncology and Neurology is preferred
- Experience with NDA/BLA/MAA submission
- Prior people management experience
Benefits
- Merit-based salary increases
- Short incentive plan participation
- 401(k) plan
- Medical, dental, vision, life and disability insurances
- Leaves provided in line with your work state
- Flexible paid time off
- 11 paid holidays
- Additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
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