Empleo / Almirall

Almirall

Associate director, safety physician

Ubicación
SANT FELIU DE LLOBREGAT
Jornada
Jornada completa
Publicada
hace 3 meses

La oferta

Estamos construyendo el futuro de la dermatología médica centrándonos en las necesidades no cubiertas de los pacientes y dando a las personas el espacio para pensar de forma independiente, asumir responsabilidades y generar un impacto que de verdad importe. Nuestro propósito es sencillo: transformar la vida de los pacientes abordando necesidades reales. Trabajamos con rigor, actuamos con valentía, simplificamos lo complejo y enfocamos la innovación allí donde realmente marca la diferencia. Reconocidos como Top Employer en España desde 2008 y en Alemania desde 2025, seguimos invirtiendo en un entorno donde las personas pueden crecer y avanzar. Si quieres hacer las cosas de otra manera, este es tu lugar. 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.