SF Bay Area - Director Drug Safety Operations

I am working with a quickly growing biotech company that is looking for an experienced and dynamic Director of Pharmacovigilance Operations to lead and oversee the strategy, implementation, and continuous improvement of PV systems and processes. This role ensures compliance with global regulatory requirements, fosters operational excellence, and supports the organization's commitment to patient safety.

Key Responsibilities:

• Develop, implement, and manage PV operational strategies
• Process and evaluate aggregate adverse event reports and ICSRs
• Oversee adverse event reporting, risk management, and safety database operations
• Drive process improvements, system enhancements, and operational efficiencies within PV

Qualifications:

• Advanced degree in life sciences, pharmacy or related field preferred
• 8+ years of pharmacovigilance experience with 3+ years in a leadership role
• Comprehensive knowledge of global PV regulations and safety reporting requirements