Vice President of Pharmacovigilance

Job Summary

A company is looking for a Vice President, Pharmacovigilance and Patient Safety.

Key Responsibilities

• Lead and oversee pharmacovigilance activities, ensuring compliance with drug safety regulations
• Manage safety operations, including continuous safety data collection and regulatory reporting
• Collaborate with cross-functional teams to support clinical development and regulatory submissions

Required Qualifications

• M.D. or D.O. degree with 15+ years of experience in Drug Safety/PV in a pharmaceutical/biotech setting
• Therapeutic experience in pediatric medicine or oncology is highly desirable
• Experience leading multifaceted teams and managing drug safety processes
• Strong knowledge of regulatory requirements and guidelines, including GCP and FDA regulations
• Proven track record of successful interactions with health authorities and regulatory submissions