State Licensed Drug Safety Physician

Job Summary

A company is looking for a Director, Drug Safety Physician.

Key Responsibilities:

• Perform triage and medical review of Individual Case Safety Reports (ICSRs) and oversee expedited safety reporting
• Participate in the preparation and review of aggregate safety documents and clinical trial regulatory filings
• Conduct safety data review, signal detection, and participate in safety management team meetings

Required Qualifications:

• MD with 6+ years of experience in Clinical Development Drug Safety/Medical Review in the biotech/pharmaceutical industry
• Proficiency in Argus global safety database and medical review activities
• Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.)
• Experience in developing safety risk language and risk management strategies
• Ability to collaborate effectively across functions