ASSOCIATE DIRECTOR, SAFETY PHYSICIAN

Almirall; Sant Feliu de Llobregat; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Almirall is seeking an Associate Director, Safety Physician to provide medical leadership for patient safety across clinical development and post-marketing for assigned products. You will oversee medical review, signal detection, DSUR/PSUR/RMP preparation, and risk management in alignment with GVP and global regulations.

The role requires 8–10+ years in pharmacovigilance, MD degree, and fluency in English. You will work with Clinical, Regulatory and Medical Affairs to ensure proactive risk

Qualifications

• 8–10+ years in pharmacovigilance/drug safety including clinical safety, medical review and signal management.
• MD degree; clinical experience is a plus.
• Fluency in English and strong communication skills.

Responsabilités

• Lead medical review of 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; support regulatory responses.
• Advise on protocol safety design, stopping rules, and DMC interactions; support FIH/pivotal studies.
• Ensure PV compliance and audit/inspection readiness with vendors and affiliates.

Connaissances

Medical leadership

Pharmacovigilance

Regulatory compliance

Signal detection

DSUR/PSUR

English fluency

Cross-functional collaboration

Formation

MD degree

Description du poste

We’rebuilding 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 andfocusour innovation where it makes a difference.

Recognisedas 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.

Position Summary/ 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 and Medical Affairs to ensure proactive risk management, timely safety communications, and inspection readiness; and also 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 certifications and experience:

• MD, clinical experience is a plus.
• 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.