State Licensed Drug Safety Physician

Job Summary

To advance the development of cutting-edge antibody therapies, the full-time salaried State Licensed Drug Safety Physician will manage Individual Case Safety Report (ICSR) reviews, oversee safety monitoring, and provide medical safety input for clinical trial documents in a remote working environment.

Key Responsibilities

• Perform triage and medical review of ICSRs and oversee cases for expedited safety reporting
• Lead cross-functional medical review discussions and participate in the preparation of aggregate safety review documents
• Collaborate on safety data review and participate in safety management team meetings

Required Qualifications

• MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience
• Degree in epidemiology or extensive knowledge in Epidemiology/Pharmacoepidemiology preferred
• Proficiency in Argus global safety database and medical review activities
• Experience in safety surveillance and signal detection activities
• Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.)