Pharmacovigilance Director

Job Summary

A company is looking for a Director, Pharmacovigilance to lead global safety and pharmacovigilance activities across clinical-stage CAR-T programs in autoimmune diseases.

Key Responsibilities:

• Lead pharmacovigilance strategy and serve as the safety lead on study teams
• Oversee case processing, signal detection, and risk assessment activities
• Ensure compliance with global pharmacovigilance regulations and support health authority interactions

Qualifications:

• Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred
• Minimum of 8-10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry
• Strong knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
• Experience supporting clinical trials, including safety monitoring and signal detection
• Prior experience in cell and gene therapy or related therapeutic areas strongly preferred