Associate director, safety physician
Almirall Sant Feliu de Llobregat
Experteer Overview
In this role, you provide medical leadership for patient safety across clinical development and post-marketing. You oversee medical review, signal detection, and benefit-risk assessment to ensure compliance with global regulations. You partner with Clinical, Regulatory, and Medical Affairs to enable proactive risk management and timely safety communications.You engage with health authorities as needed and help maintain inspection readiness. This position offers influence across development stages and a focus on impactful patient outcomes.
Compensaciones / Beneficios- Lead medical review of safety data and 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; support 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
- MD in Medicine; 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
- Fluency in English and good communication skills
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