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+ years in pharmacovigilance/drug xqziphu 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)
🏢 Jobrapido
📍 Barcelona