Sr/Executive Director/VP – Head of Drug Safety & Pharmacovigilance – Oncology

Position Summary:

We are seeking an experienced and strategic Head of Drug Safety & Pharmacovigilance on behalf of our biopharmaceutical client based in the San Francisco Bay Area (US).

The selected candidate will be responsible for leading the global safety strategy while ensuring hands-on oversight of pharmacovigilance (PV) operations across a diverse biologics pipeline. This role requires deep expertise in oncology, along with exposure to metabolic and immunology safety, and the ability to support both development and commercial-stage assets.

This is a senior leadership role requiring strong regulatory knowledge, cross-functional collaboration, and the ability to build and scale global PV capabilities.

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

Qualification & 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