Director of Medical Safety

Job Summary

A company is looking for a 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 meet regulatory requirements and inspection readiness
• Coordinate and author aggregate safety reports and risk management plans

Required Qualifications, Training, and Education

• At least 8 years of experience in drug safety, with a minimum of 5 years in surveillance/risk management
• Degree in a life science field (e.g., nursing, pharmacy) or a relevant scientific/technical discipline
• Expert knowledge of pharmacovigilance regulations and medical writing skills
• In-depth knowledge of medical and drug terminology and the clinical development process
• Familiarity with MedDRA and safety databases