Associate Director of Medical Safety

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/programs
• Ensure up-to-date processes and procedures for safety governance, signal management, and risk management
• Produce aggregate safety reports and provide strategic input into regulatory submissions

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, including aggregate safety reports and risk management plans
• In-depth knowledge of medical and drug terminology, as well as the clinical development process
• Familiarity with MedDRA and safety databases