Senior Safety Physician, Associate Director

Almirall; Sant Feliu de Llobregat; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Almirall is seeking an Associate Director, Safety Physician to provide medical leadership across clinical development and post‑marketing safety. You will oversee medical review, signal detection, and aggregate reporting in line with ICH and GVP requirements.

Collaborating with Clinical, Regulatory, Epidemiology and Medical Affairs teams, you will drive risk management, DSUR/PSUR/RMP activities and safety communications, while ensuring inspection readiness and strong cross‑functional leadership.

Qualifications

• MD degree required.
• 8–10+ years of pharmacovigilance experience.
• Knowledge of ICH, GVP and global safety regulations.
• Fluency in English.
• Experience across clinical development and post-market safety.

Responsabilités

• Lead medical review of data and chair safety review meetings.
• Oversee signal detection/evaluation and benefit–risk assessments.
• Author/review DSURs, PBRER/PSURs, RMPs and labeling updates; support regulatory responses.
• Advise on protocol safety design and DMC interactions; support FIH and pivotal studies.
• Ensure PV compliance and inspection readiness with vendors and affiliates.

Connaissances

Cross-functional leadership

Clinical judgment

Medical review

Regulatory liaison

Risk management

Formation

MD (Doctor of Medicine) degree

Description du poste

Almirall is seeking an Associate Director, Safety Physician to provide medical leadership across clinical development and post‑marketing safety. You will oversee medical review, signal detection, and aggregate reporting in line with ICH and GVP requirements.

Collaborating with Clinical, Regulatory, Epidemiology and Medical Affairs teams, you will drive risk management, DSUR/PSUR/RMP activities and safety communications, while ensuring inspection readiness and strong cross‑functional leadership.