Senior Medical Director, Drug Safety

Job Summary

To ensure compliance and quality in drug safety practices, the full-time remote Senior Medical Director, Drug Safety will manage medical oversight of safety vendors, conduct safety assessments, and collaborate with cross-functional teams on regulatory submissions and safety reporting.

Key responsibilities

• Oversee medical safety assessments and ensure timely reporting of adverse events and safety data
• Develop and maintain standard operating procedures and guidance documents for regulatory compliance
• Lead safety signal management and benefit-risk assessments while supporting inspection readiness activities

Required qualifications

• 10+ years of experience in drug safety or pharmacovigilance within a sponsor or CRO environment
• Medical degree with preferred training in medical or radiation oncology, hematology, or a related field
• Comprehensive knowledge of global drug safety regulations and commercial safety databases
• Experience in preparing aggregate safety reports and updates for clinical documents
• Strong project management skills with the ability to prioritize tasks effectively