OverviewIn this role you lead medical safety oversight across clinical development and post-marketing for assigned products.

You collaborate with cross-functional teams to ensure proactive risk management, timely safety communications, and regulatory readiness.

You will oversee safety data review, signal management, and benefit–risk assessment, while contributing to DSURs, PBRER/PSURs, and labeling updates.

Your work drives patient safety and regulatory compliance at scale.

ResponsabilidadesLead medical review of individual and aggregate safety data and chair 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

Requisitos principalesMD degree

8–10+ years of experience in pharmacovigilance

Knowledge of ICH, GVP, and integral safety regulations

Fluency in English

Strong clinical judgment

Cross-functional leadership

Effective communication

Pharmacovigilance oversight

Signal detection and evaluation

DSURs, PBRER/PSURs, RMPs

📌 Associate Director Safety Physician (Barcelona)
🏢 Almirall
📍 Barcelona