ASSOCIATE DIRECTOR, SAFETY PHYSICIAN
hace 4 días
Sant Feliu de Llobregat
Position Summary / Mission Siga leyendo para descubrir lo que necesitará para tener éxito en este puesto, incluyendo habilidades, cualificaciones y experiencia. 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. 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. 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 pivotal studies., • 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 including clinical safety, medical review and signal management., • Knowledge of GVP, GCP and global safety regulations., • Strong clinical judgment. xcskxlj, • Fluency in English and good communication skills. #J-18808-Ljbffr
Maria del carmen P.Activo hace 1 hora
