ASSOCIATE DIRECTOR SAFETY PHYSICIAN

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

We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.

Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

MISSION

The Associate Director, Safety Physician provides medical leadership for patient safety across clinical development and post-marketing for assigned products. The role oversees medical review, signal detection/management, aggregate reporting, and benefit–risk assessment in compliance with global regulations and GVP. The incumbent partners with Clinical, Regulatory, Epidemiology, and Medical Affairs to ensure proactive risk management, timely safety communications, and inspection readiness; and engages with health authorities as needed.

Core Responsibilities

• Lead medical review of individual and aggregate safety data; chair or 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; 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.

Required Education And Experience

• MD (Doctor of Medicine) degree required.
• 8–10+ years of experience in pharmacovigilance.
• Knowledge of ICH,GVP, and global safety regulations.
• Fluency in English.

Preferred Skills And Competencies

• Experience across both clinical development and post-market safety.
• Authority interactions and inspection experience.
• Strong clinical judgment, communication, and cross-functional leadership.