Director of Safety and Pharmacovigilance

Job Summary

To support the global safety strategy for cell therapy programs, the full-time remote Sr. Director of Safety and Pharmacovigilance will manage signal detection, risk management, and regulatory compliance while collaborating cross-functionally to enhance clinical and regulatory strategies.

Key responsibilities

• Serve as the safety subject-matter expert for cell therapy programs, including risk management and signal detection
• Provide strategic safety input for clinical development plans and regulatory submissions
• Oversee medical safety activities and ensure compliance with global safety regulations

Required qualifications

• MD degree
• 8+ years of experience in pharmacovigilance and drug safety, with at least 3 years in a leadership role
• Direct experience with cell therapy, gene therapy, or autoimmune/CNS indications preferred
• Experience in clinical-stage biotech with prior BLA/MAA and/or launch experience is a plus
• Strong knowledge of global PV regulations and safety standards