Associate Medical Review Director

Role: Medical Reviewer within Patient Safety at Novo Nordisk, focusing on evaluating and validating adverse event reports to ensure accurate medical interpretation, compliance with US regulations, and contribution to safety profiles. Responsibilities: review individual case safety reports (ICSRs), assess seriousness, expectedness, causality, and regulatory reportability, perform aggregate safety data reviews, provide medical guidance to case processing teams, support regulatory submissions, and ensure adherence to FDA/ICH guidelines. Collaboration: work closely with Global Safety, Clinical, Medical, Regulatory, and Marketing teams, serving as internal safety advisor and SME. Requirements: M.D./D.O. with current clinical knowledge, at least one-year pharma industry experience, computer literacy, MedDRA coding proficiency, strong communication skills. High-value biopharma specifics: focus on post-marketing safety surveillance, regulatory compliance (FDA, ICH), pharmacovigilance, and risk assessment. Work setup: onsite with minimal overnight travel (0-10%). Experience in pharmaceutical safety, regulatory reporting, and adverse event evaluation is essential.