03 ago
|
Almirall
|
San Feliú de Llobregat
03 ago
Almirall
San Feliú de Llobregat
Experteer Overview
¡Inscríbase sin demora! Se espera un gran volumen de solicitantes para el puesto que se detalla a continuación, no espere para enviar su CV.
In this role you will provide medical leadership for patient safety across clinical development and post-marketing for assigned products. You will oversee medical review, signal detection/management, and benefit–risk assessment in line with global regulations, partnering with Clinical, Regulatory and Medical Affairs to ensure proactive risk management and timely safety communications. You will work toward inspection readiness and engage with health authorities as needed, shaping safety strategies across development and post-market activities.
Compensaciones / Beneficios
• Lead medical review of individual and aggregate safety data; participate in 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 maintain audit/inspection xqbhyrx readiness with vendors and affiliates
Responsabilidades
• MD
• 8–10+ years in pharmacovigilance/drug safety including clinical safety, medical review and signal management
• Knowledge of GVP, GCP and general safety regulations
• Strong clinical judgment
• Fluency in English and good communication skills
Requisitos principales
•
📌 ASSOCIATE DIRECTOR, SAFETY PHYSICIAN (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat