Patient Safety, Medical Director

Vertex Pharmaceuticals seeks a Medical Director for Patient Safety to provide pharmacovigilance and safety expertise across assigned product portfolios. The role manages safety assessments, regulatory compliance, and risk mitigation activities throughout the product lifecycle, reporting to a Global Patient Safety Disease-area Safety Head.

Responsibilities

• Lead safety and risk management processes including chairing disease-area safety and product teams
• Monitor benefit-risk profiles and identify, prioritize, and analyze clinical safety signals
• Develop safety-related responses to regulatory health authority inquiries
• Review emerging safety data from single case reports, literature, and aggregate sources
• Participate in protocol development and analyze safety data from clinical trials

Requirements

• MD, DO, or MB degree required
• 5+ years experience in safety, pharmacovigilance, or equivalent combination
• Broad knowledge of pharmacovigilance regulations and global regulatory requirements
• Expertise in ICSR case review and aggregate safety analysis
• Experience with NDA/MAA, RMP, and REMS regulatory approval activities
• Strong written and verbal communication skills for complex safety matters
• Demonstrated ability to influence stakeholders and defend positions on safety issues