- California, United States
- Full-time · Director
- 12+ years
Leading evolution of drug safety framework as we enter Phase 3, balancing strategic oversight of external partners with hands-on systems building.
Responsibilities
- Collaborating with external partners, CROs, and affiliates to manage PV vendors and agreements, and Safety Management Plans
- Providing expert oversight for safety data review, aggregate analyses, and producing/submitting safety reports
- Working with Medical Monitors and Clinical Scientists to facilitate safety signal detection, validation, and management
- Ensuring robust safety surveillance through continuous monitoring of emerging safety data from clinical trials and literature
- Overseeing global PV systems and processes, including case processing and aggregate reporting
Requirements
- degree in healthcare (RN, PharmD, PA, or NP)
- Nice to have: building or scaling a pharmacovigilance function