Pharmacovigilance Operations Director
Job Summary
Leading the development of pharmacovigilance capabilities, the full-time remote Director/Senior Director, Pharmacovigilance Operations will manage drug safety systems, oversee safety operations, and ensure regulatory compliance as the company transitions to a commercial biopharmaceutical organization.
Key Responsibilities
- Develop and execute the pharmacovigilance strategy for late-stage clinical development and product launch
- Lead readiness activities for transitioning from clinical-stage to commercial-stage pharmacovigilance
- Establish processes for signal detection, safety surveillance, and benefit-risk management
Required Qualifications
- Advanced degree in a health or life sciences discipline (MD, PharmD, PhD, RN/NP, or equivalent)
- 10+ years of pharmaceutical/biotechnology experience with 7+ years in pharmacovigilance/drug safety
- Experience managing outsourced pharmacovigilance operations and vendors
- Proven track record with NDA/BLA preparation and post-marketing pharmacovigilance
- Strong knowledge of global pharmacovigilance regulations and reporting requirements
Complete Job Description
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