💼 About This Role

You'll lead pharmacovigilance strategy for a clinical-stage biopharmaceutical pipeline, driving safety evaluations across pre- and post-approval phases. You'll ensure global regulatory compliance through proactive risk management and signal detection.

🎯 What You'll Do

• Lead pharmacovigilance strategies for assigned therapeutic products
• Oversee signal detection, evaluation, and risk-benefit assessments
• Chair Product Safety Committee meetings and escalate to Executive Safety Committee
• Provide medical review of safety data from clinical trials and post-marketing sources

📋 Requirements

• MD, MBBS, or equivalent medical degree
• 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience
• Strong understanding of US and EU pharmacovigilance regulations
• Experience supporting drug safety in registrational clinical studies

✨ Nice to Have

• Prior IND/NDA/BLA submission experience
• Leadership in matrix team environments