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
• Lead cross-functional medical review discussions and participate in safety data review activities
• Contribute to the preparation and review of aggregate safety documents and ensure compliance with global regulatory requirements

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 benefit-risk management strategies for drug safety
• Ability to provide safety input to clinical development plans and regulatory submissions