Associate Medical Review Director

The Position (Associate Director Medical Review)

Responsible for performing medical review and validation of incoming adverse events, ensuring correct medical interpretation (including evaluation of expectedness and reportability). Ensures consistency in evaluation of adverse event cases. Ensures compliance with US drug/device safety reporting regulations, ICH guidelines, and internal procedures for evaluation, reporting, and surveillance of clinical and post-marketing safety information. Contributes to and maintains the company’s product safety profile with HQ.

• Liaise with Global Safety and NNI medical/clinical/regulatory on safety matters
• Narrative writing, medical evaluation of cases, database reconciliation, protocol review
• Provide medical input in ICSR safety review (post-marketing sources)
• Review individual safety reports: medical content, expectedness/listedness, regulatory status for expedited reporting, and possible signal detection
• Perform aggregate medical review of post-marketing non-serious adverse events with Global Safety
• Handle local aggregate report activities (e.g., PBRERs, PADERs) with safety input
• Guide case processing personnel on seriousness, expectedness/listedness, and causality for FDA reportability; serve as Patient Safety lead SME in PRB meetings
• Determine regulatory submissions for ICSDRs and perform quality checks with case processing teams
• Support internal/external training (e.g., onboarding and annual safety training)
• Maintain up-to-date knowledge of FDA/ICH and industry safety surveillance/reportability standards; perform gap analysis and impact assessment
• Provide Patient Safety input to Local Labeling Committee and review/disseminate affiliate mailbox information

• 0–10% overnight travel

• MD/DO required; up-to-date knowledge of clinical/therapeutic principles
• Minimum 1 year pharmaceutical industry experience
• Computer literacy
• Excellent written/verbal English
• MedDRA coding experience required

For accommodation requests only: