Associate Director, Safety Physician (Madrid)

Position Summary The Associate Director, Safety Physician provides medical leadership for patient safety across clinical development and post-marketing for assigned products. The role oversees medical review, signal detection/management, aggregate reporting, and benefit–risk assessment in compliance with global regulations and GVP. Core Responsibilities Lead medical review of individual and aggregate safety data;
chair or contribute to safety review meetings. Oversee signal detection/evaluation and benefit–risk assessments;
recommend risk minimization actions. Author/review DSURs, PBRER/PSURs, RMPs, and labeling updates;
contribute to regulatory responses. Advise on protocol safety design, stopping rules, and DMC interactions;
support FIH and pivotalstudies. Ensure PV compliance and audit/inspection readiness with vendors and affiliates. Required Certifications and Experience MD, clinical experience is a plus. 8–10+ years in pharmacovigilance/drug safety inc...

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