Director, Global Patient Safety Surveillance
Revolution Medicines · Basel, Switzerland
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Role summary
Revolution Medicines seeks a Director of Global Patient Safety Surveillance to lead the design, development, and execution of core pharmacovigilance processes. The role involves managing safety surveillance activities, regulatory compliance, and expert consultation across clinical development and regulatory submissions for an oncology-focused company.
What they're looking for
- Extensive experience in pharmacovigilance and global patient safety processes
- Deep knowledge of regulatory requirements (GCP, GVP, GDocP) and health authority expectations
- Demonstrated expertise in safety risk management, signal detection, and benefit-risk analysis
- Experience with regulatory submissions and NDA/filing packages
- Strong understanding of clinical development and pharmacovigilance quality systems
- Ability to lead cross-functional teams and provide strategic consultation
What you'll be doing
- Design, develop, and maintain core global patient safety processes and compliance frameworks
- Manage execution and delivery of safety reports (RMPs, DSURs, PSURs) per regulatory standards
- Provide expert guidance on pharmacovigilance portions of regulatory filings and clinical documents
- Develop controlled documentation for pharmacovigilance oversight and quality system demonstration
- Collaborate with EU Qualified Person for Pharmacovigilance on European regulatory compliance
Privacy & handoff
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