Safety Physician

📋 Description

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit
• Work with CRO Safety Physicians/Team and Dragonfly's Medical Directors, Clinical Scientists and
• Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs
• Act as the point of contact accountable for setting up and running DSMBs or safety data review
• Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies

🎯 Requirements

• MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech
• Clinical trial experience, including oncology drug safety with least 3 years being in early
• Experience authoring, reviewing, and providing input to drug-safety related regulatory reports
• Successful involvement in regulatory agency interactions or inspections
• Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and
• Solid medical knowledge and familiarity with medical concepts and terminology used in