Local Medical Safety Specialist – 12‑month contract in Madrid

About the role

Johnson & Johnson is seeking a Local Medical Safety Specialist to join its pharmacovigilance team in Madrid on a 12‑month fixed‑term contract. The role supports proactive benefit‑risk management throughout the product life‑cycle by translating global safety data into local insights and actions.

Key responsibilities

• Manage the local Pharmacovigilance (PV) system in compliance with Spanish regulations and company policies.
• Conduct benefit‑risk activities and ensure proactive risk management for marketed products.
• Oversee collection, review, reporting, reconciliation and follow‑up of Individual Case Safety Reports (ICSRs).
• Maintain oversight of vendor activities related to literature processing and ICSR handling.
• Ensure audit and inspection readiness at the local level and monitor inbound/outbound ICSR compliance.
• Collaborate with Medical Safety Quality to perform ICSR reconciliations and reviews.

Required profile

• Experience in pharmacovigilance or medical safety within the pharmaceutical or medical device industry.
• Strong knowledge of Spanish PV regulations and global PV standards.
• Ability to work independently and coordinate with regional and global teams.
• Excellent attention to detail and strong organizational skills.

Required skills

• Pharmacovigilance
• ICSR management
• Benefit‑risk management
• Regulatory compliance
• Audit/inspection readiness