Medical Review Director

Job Summary

A company is looking for a Director, Medical Review to lead medical safety oversight and ensure compliance in pharmacovigilance.

Key Responsibilities:

• Oversee CRO individual case medical reviewers and review ICSRs, including narrative coding and causality assessments
• Provide medical advice on adverse event case management and collaborate with cross-functional teams for accurate medical narratives
• Participate in the development of SOPs, support audits, and contribute to process improvement initiatives within pharmacovigilance

Required Qualifications:

• MD required; Board Certification preferred
• Significant pharmacovigilance/drug safety expertise, including medical review of ICSRs
• Knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance
• Experience managing external vendors and collaborating with cross-functional teams
• Strong clinical acumen and experience in individual case reviews