Director, Drug Safety Physician

📋 Description

• Perform triage and medical review of Individual Case Safety Reports (ICSRs)
• Oversee cases and Analysis of Similar Events (AOSEs) supporting expedited safety reporting
• Lead cross-functional medical review discussions related to ICSR assessment
• Participate in preparing, writing, and reviewing aggregate safety reports, including DSURs
• Review safety sections of clinical trial documents and regulatory submissions
• Lead or contribute to scientific literature reviews and prepare written summaries supporting

🎯 Requirements

• MD or equivalent medical degree
• 6+ years of relevant clinical development drug safety or medical review experience in biotech/pharma
• Experience with medical review of ICSRs and periodic safety reports
• Experience with late-stage or clinical development programs
• Working proficiency with Argus global safety database
• Experience in safety surveillance and signal detection

🎁 Benefits

• Salary: $280,000–$311,000 annual base salary
• Performance-based bonus opportunity
• Equity grant opportunities
• Health and welfare benefits
• Retirement benefits
• Unlimited PTO