Director, Global Patient Safety Surveillance

Revolution Medicines · London, UK

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Role summary

Revolution Medicines seeks a Director of Global Patient Safety Surveillance to lead the design, development, and maintenance of core safety processes. This role requires expertise in pharmacovigilance, regulatory compliance, and safety risk management across an oncology portfolio.

What they're looking for

Extensive pharmacovigilance and clinical safety expertise with demonstrated subject matter knowledge
Proficiency in GCP, GVP, and GDocP regulatory frameworks and global compliance requirements
Experience designing and managing safety processes including signal detection, risk management, and aggregate reporting
Knowledge of regulatory report preparation (DSURs, PSURs, RMPs, NDA modules) and labeling strategy
Familiarity with EU pharmacovigilance requirements and qualified person responsibilities
Track record of developing and maintaining quality systems aligned with global regulations

What you'll be doing

Lead design, development, and maintenance of core global patient safety processes in compliance with regulatory standards
Manage execution and delivery of safety documentation including RMPs, DSURs, and PSURs per global requirements
Provide expert consultation to development and filing teams on pharmacovigilance aspects of regulatory submissions
Develop controlled documentation demonstrating oversight and control of pharmacovigilance aggregate reporting
Collaborate with EU qualified person to ensure European compliance and inspection readiness

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Date posted3 days ago

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