Director, Drug Safety Operations
San Francisco Bay Area
A late-stage Biopharmaceutical company is seeking a Director, Drug Safety Operations position to join its rapidly expanding team. This company has a rich pipeline of therapies within the Cardiovascular and Neurological therapeutic areas. With corporate partnerships with global billion-dollar pharma organizations this company has the financial backing, and financial stability, that you normally don't witness in "start-up" companies. Now is a pivotal time to get in with this group as this company is on track for explosive growth when its first indication goes to market!
The Director, Drug Safety Operations will have the following responsibilities:
- Provide leadership and direction to the Drug Safety department for adverse event case management
- Support study teams and projects
- Oversight of maintenance of drug safety database
- Collaborate to support risk management and pharmacovigilance for all clinical trials.
- Lead preparation of safety-related plans with partners and CROs
- Assist with preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, etc.
- Train staff and external CRO's on drug safety principles and procedures
- Manage and mentor staff and assign responsibilities as appropriate to meet timelines and quality metrics
The ideal candidate will have the following skill set:
- Bachelor's degree in life sciences, nursing, pharmacy, or medicine
- 3 years PV/Drug Safety Management experience
- 5+ years hands on case processing experience
Excellent Salary + Full Health Care Benefits + Targeted Bonus + LTI (Options and RSU's) + Retirement Plan