ASSOCIATE DIRECTOR, SAFETY PHYSICIAN

Almirall; Sant Feliu de Llobregat; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Almirall is seeking an Associate Director, Safety Physician based in Sant Feliu de Llobregat, Spain. This role provides medical leadership for patient safety in clinical development and post-marketing. Duties include overseeing safety data review, risk management, and compliance with global regulations.

The ideal candidate should have at least 8–10 years of experience in pharmacovigilance, a strong clinical background, and fluency in English. Join us to ensure timely safety communications and regulatory readiness.

Formación

• Minimum of 8–10+ years in pharmacovigilance/drug safety.
• Experience in clinical safety and medical review.
• Knowledge of GVP, GCP and global safety regulations.

Responsabilidades

• Lead medical review of individual and aggregate safety data.
• Oversee signal detection/evaluation and benefit–risk assessments.
• Author/review DSURs, PBRER/PSURs, and RMPs.
• Advise on protocol safety design and DMC interactions.
• Ensure compliance and audit readiness.

Conocimientos

Medical review of safety data

Signal detection

Fluency in English

Communication skills

Clinical judgment

Educación

MD

Descripción del empleo

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.