Sr/Executive Director/VP – Head of Drug Safety & Pharmacovigilance – Oncology
Alpha Clinical · San Francisco, CA · 2 mo ago
Business DevelopmentFull-time
Key Responsibilities
- Define and implement global pharmacovigilance and risk management strategies across oncology, metabolic, and immunology portfolios
- Oversee PV activities across Phase I–III clinical trials, including safety data review, SAE handling, and aggregate reporting (DSURs, PSURs, PADER, PBRER)
- Lead signal detection, risk mitigation, and benefit-risk assessments for complex therapeutic profiles
- Manage safety sections for regulatory submissions (INDs, NDAs) and respond to FDA/EMA queries
- Ensure compliance with global PV regulations (21 CFR Part 312, ICH E2 guidelines, GVP, GMP)
- Represent the safety function in regulatory meetings, audits, and inspection readiness activities
- Oversee internal safety review processes and support DSMB coordination
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and CRO partners
- Lead and mentor a growing PV team and contribute to global safety operations and capability building
Qualifications & Profile
- MD (preferred), PharmD, or PhD in Life Sciences
- 10+ years of experience in drug safety/pharmacovigilance
- 5+ years of leadership experience in a biopharmaceutical environment
- Strong oncology safety experience (ADCs, bispecifics, IO agents); exposure to metabolic/immunology is an advantage
- Proven experience with clinical trial safety and regulatory submissions (US/EU)
- Proficiency in safety databases (Argus, ArisG, Oracle)
- Strong understanding of signal detection, safety governance, and global PV regulations
- Excellent leadership, analytical, and communication skills
- Ability to manage cross-functional teams across global time zones