Associate Medical Review Director

Responsibilities:
- Perform medical review/validation of incoming adverse events, ensuring correct medical interpretation (expectedness/listedness, reportability) and consistent evaluation.
- Ensure compliance with US drug/device safety reporting regulations, ICH guidelines, and internal procedures for clinical and post-marketing safety information.
- Liaise with Global Safety and NNI medical/clinical/regulatory on safety matters.
- Write narratives; evaluate cases; reconcile databases; review protocols.
- Provide medical input for ICSRs (post-marketing sources) and review individual safety reports for medical content, expedited reporting status, and potential signal detection.
- Conduct aggregate medical review of post-marketing non-serious adverse events; support local aggregate reporting (e.g., PBRERs/PADERs).
- Guide case processing on seriousness, expectedness/listedness, and causality for FDA reportability; serve as Patient Safety lead SME in PRB meetings.
- Determine regulatory submissions for ICSRs and perform quality checks with case processing teams.
- Maintain up-to-date knowledge of FDA/ICH guidance; conduct gap/impact analyses for new/revised regulations.
- Provide Patient Safety input to labeling committees and review/disseminate affiliate mailbox information.

Qualifications:
- M.D./D.O. 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.

Travel: 0–10% overnight.

Compensation/Benefits (as stated): Base $165,000–$220,000 + eligible for company bonus; long-term incentive and/or vehicles depending on level; medical/dental/vision, life/disability, 401(k), flexible spending, EAP, tuition reimbursement, and other voluntary benefits.

Application instruction (accommodation): Call 1-855-411-5290 for accommodation requests only.