ph3Position Summary / Mission /h3 pThe 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. The incumbent partners with Clinical, Regulatory and Medical Affairs to ensure proactive risk management, timely safety communications, and inspection readiness, and also engages with health authorities as needed. /p h3Core Responsibilities /h3 ul liLead medical review of individual and aggregate safety data; chair or contribute to safety review meetings. /li liOversee signal detection/evaluation and benefit–risk assessments; recommend risk minimization actions. /li liAuthor/review DSURs, PBRER/PSURs, RMPs,



and labeling updates; contribute to regulatory responses. /li liAdvise on protocol safety design, stopping rules, and DMC interactions; support FIH and pivotal studies. /li liEnsure PV compliance and audit/inspection readiness with vendors and affiliates. /li /ul h3Required Certifications and Experience /h3 ul liMD, clinical experience is a plus. /li li8–10+ years in pharmacovigilance/drug safety including clinical safety, medical review and signal management. /li liKnowledge of GVP, GCP and integral safety regulations. /li liStrong clinical judgment. /li liFluency in English and good communication skills. /li /ul /p #J-18808-Ljbffr

📌 ASSOCIATE DIRECTOR, SAFETY PHYSICIAN (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat