Overview
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In this role you will provide medical leadership for patient safety across clinical development and post-marketing for assigned products. You will oversee medical review, signal detection/management, and benefit–risk assessment in line with integral regulations, partnering with Clinical, Regulatory and Medical Affairs to ensure proactive risk management and timely safety communications. You will work toward inspection readiness and engage with health authorities as needed, shaping safety strategies across development and post-market activities.
Responsabilidades
Lead medical review of individual and aggregate safety data; participate in 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 maintain audit/inspection readiness with vendors and affiliates
Requisitos principales
MD
8–10+ xqbhyrx years in pharmacovigilance/drug safety including clinical safety, medical review and signal management
Knowledge of GVP, GCP and global safety regulations
Strong clinical judgment
Fluency in English and good communication skills
strong communication skills
clinical judgment
leadership abilities
pharmacovigilance
medical review
signal detection

📌 ASSOCIATE DIRECTOR, SAFETY PHYSICIAN (Barcelona)
🏢 Almirall
📍 Barcelona