Vice President, Drug Safety

Vice President, Drug Safety

Direct Hire Full-Time Role

Salary Range: $330,000 - $350,000 per year

Location: Palo Alto, CA - Hybrid Role

Job Summary:

The Vice President, Drug Safety, will be responsible for the strategic and operational oversight of global drug safety activities across both clinical development and eventually post-marketing

Duties and Responsibilities:

• Lead global pharmacovigilance strategy across clinical programs and marketed products
• Oversee day-to-day safety operations, including case review, signal detection, and risk management
• Author and review safety-related regulatory documents (DSURs, PSURs, RMPs, IBs, safety sections of INDs/NDAs)
• Serve as the primary point of contact for global regulatory agencies on safety matters
• Collaborate closely with Clinical, Regulatory, and Medical Affairs to ensure aligned safety strategies
• Lead safety governance activities, including safety review committees and signal evaluation
• Manage vendor relationships and ensure compliance with global PV regulations

Requirements and Qualifications:

• MD or equivalent required
• Extensive experience in pharmacovigilance across late-stage clinical development stages
• Global experience and deep understanding of regulatory requirements across major markets (FDA, EMA, etc.)
• Demonstrated experience authoring and reviewing key regulatory and safety documents
• Hands-on leadership style with experience in small to mid-sized biotech environments
• Strong cross-functional collaboration and communication skills

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