Director, Pharmacovigilance

The Director, Pharmacovigilance role is based in the United States.

Accountabilities

• Oversight of end-to-day pharmacovigilance operations including case intake, triage, medical review support, and expedited safety reporting in compliance with global regulations
• Adherence to FDA, EMA, and ICH pharmacovigilance requirements across all clinical programs
• Management of PV vendors and CRO partnerships, ensuring high-quality service delivery, data accuracy, and regulatory compliance
• Preparation and review of aggregate safety reports including DSURs, PSURs/PBRERs, IND safety reports, and related regulatory submissions
• Development and maintenance of SOPs, safety databases, and Pharmacovigilance System Master File documentation
• Drive signal detection activities, safety data review, trend analysis, and participation in risk management planning
• Collaboration cross-functionally with Clinical Development, Regulatory Affairs, and Medical Affairs to ensure aligned safety strategies
• Ensuring inspection readiness through audit support, internal quality oversight, and continuous process improvement initiatives
• Contribution to strategic planning and scaling of pharmacovigilance systems and infrastructure

Requirements

• Advanced degree in a health-related field (MD, PharmD, PhD, MS, RN, NP, or PA) with 10+ years of pharmacovigilance experience in biotech or pharmaceutical environments
• Strong expertise in global pharmacovigilance regulations (FDA, EMA, ICH) and safety reporting requirements
• Proven experience managing outsourced PV models, including oversight of CROs and external vendors
• Hands-on experience with safety databases, case processing workflows, and aggregate reporting processes
• Background in clinical-stage drug development, preferably in oncology, cell therapy, or gene therapy
• Strong analytical and problem-solving skills with the ability to interpret safety data and identify risks
• Excellent communication skills and ability to collaborate across scientific, regulatory, and operational teams
• Experience ensuring inspection readiness and supporting regulatory audits or health authority inspections
• Strong leadership mindset with the ability to operate effectively in a fast-paced, evolving biotech environment

Benefits

• Competitive salary range of $204,000 - $305,000 USD depending on experience and location
• Comprehensive medical, dental, and vision insurance plans
• 401(k) retirement plan with company matching contributions
• Generous paid time off policy and flexible work arrangements
• Employee commuter benefits and cell phone stipend
• Opportunities to work on cutting-edge immunotherapy programs with high patient impact
• Collaborative and mission-driven work environment focused on innovation and scientific excellence