Associate Medical Director, Global Safety Medical Review

Role: Associate Medical Safety Director responsible for medical review and safety assessment of drug and device safety data within pharmacovigilance. Responsibilities include daily causality assessment of ICSRs, evaluating safety signals, supporting safety data review and aggregate analysis, and collaborating across PV, Clinical Development, Data Management, and quality teams to ensure harmonized safety evaluation. The role also involves assessing medical device safety information and supporting regulatory reporting. Requirements: MD degree with at least 1 year of clinical practice, 3+ years in pharmacovigilance or medical review within industry, strong clinical acumen across multiple therapeutic areas, proficiency in safety data synthesis and interpretation, and knowledge of global PV regulations (FDA, EU, ICH). Preferred skills include experience with medical device safety and combination products and familiarity with clinical trial safety reporting. The role demands excellent communication, analytical, and cross-functional collaboration skills, with the ability to work in a fast-paced environment. Engagement with internal teams and vendors is critical. Location is not specified, but the role involves interfacing across departments. The position offers competitive salary and benefits, including bonuses and incentives.