Medical Safety Associate Director

Job Summary

A company is looking for an Associate Director, Medical Safety (Scientist).

Key Responsibilities

• Lead cross-functional safety management teams and drive safety strategy for assigned products
• Ensure processes and procedures meet regulatory requirements and are inspection-ready
• Coordinate and author aggregate safety reports and risk management plans

Required Qualifications, Training, and Education

• Minimum of 6 years of experience in drug safety, with at least 4 years in surveillance/risk management
• Degree in a life science field (e.g., nursing, pharmacy) or relevant scientific/technical discipline
• Expert knowledge of pharmacovigilance regulations and aggregate safety reports
• In-depth knowledge of medical and drug terminology and the clinical development process
• Familiarity with MedDRA and safety databases