ASSOCIATE DIRECTOR, SAFETY PHYSICIAN (Madrid)

Position Summary

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.

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, clinic...