Director of Medical Safety

Job Summary

Leading the Medical Safety team, the full-time Director of Medical Safety will manage safety activities for assigned therapeutic areas, ensuring compliance with regulatory requirements and driving innovation initiatives, while collaborating closely with cross-functional teams in a remote environment.

Key responsibilities

• Leads cross-functional safety management teams and drives safety strategy for responsible products/programs
• Ensures up-to-date processes for safety governance, signal management, and clinical surveillance
• Authors and coordinates aggregate safety reports and risk management plans while providing strategic input into regulatory submissions

Required qualifications

• At least 8 years of experience in drug safety, with a minimum of 5 years in surveillance/risk management
• Expert knowledge of pharmacovigilance regulations and aggregate safety reporting
• Excellent medical writing skills and proven ability to lead interdisciplinary teams
• Degree or professional qualification in a life science field or relevant scientific/technical discipline
• Familiarity with MedDRA and safety databases