The Opportunity:

Revolution Medicines is seeking a Director level professional to lead safety management activities for its Japan entity and to serve as the Safety Management Manager (Anseki) under Japanese regulations.

The Safety Management Lead is responsible for establishing and overseeing safety management activities for the Japan entity and supporting the establishment and maintenance of the Japan Marketing Authorization Holder (MAH). In this role, the Safety Management Lead is also responsible for ensuring that all relevant pharmacovigilance requirements for Revolution Medicines are fulfilled. 

The role operates as part of the legally required three-role framework, working in close collaboration with Marketing Supervisor General (Soseki) and Quality Assurance Manager (Hinseki) to ensure effective governance across safety, quality, and regulatory domains.

Key Responsibilities:  

• Accountable for maintaining compliance with PMDA, PV Agreements, and the Japanese Risk Management Plan (J-RMP).

• Lead the design, implementation, and maintenance of the safety management system in accordance with Japanese GVP/GPSP regulations, appropriate for a pre-commercial and early-stage organization.

• Serve as the designated Safety Management Manager (Anseki) and primary safety contact for Japanese health authorities.

• Establish safety-related SOPs, procedures, and governance frameworks covering safety information collection, evaluation, reporting, and escalation.

• Provide oversight of safety activities conducted by global teams and/or external service providers, ensuring compliance with Japanese requirements including development of the J-RMP, conducting Early Post-marketing Phase Vigilance (EPPV), analysis of safety information, monitoring of benefit-risk balance, and local literature review in support of signal detection activities.

• Evaluate safety information derived from clinical development, medical activities, and external sources, and contribute to benefit-risk assessments.

• Collaborate with Medical Affairs and Clinical Development functions to ensure appropriate handling and escalation of safety information.

• Work closely with Marketing Supervisor General (Soseki) and Quality Assurance Manager (Hinseki) to ensure timely information sharing, escalation, and decision-making within the three-role framework.

• Support Soseki decision-making by providing safety input during MAH establishment and early operational phases.

• Act as the primary safety contact with PMDA and prefectural authorities, including preparation for inspections and responses to safety-related inquiries.

• Design scalable local safety governance and operating models in preparation for future commercialization.

• Ensuring that all GVP requirements are reflected in procedural documents supporting the pharmacovigilance system.

Required Skills, Experience and Education:

• Bachelor, Master, or PhD or other equivalent advanced degree in a biological or medically related field is required, and MD is preferable.

• At least 10 years or more experience in one or more of the following areas:

  • Pharmacovigilance or drug safety

  • Clinical development with responsibility for safety reporting (e.g., SAE/SUSAR, DSUR)

  • Medical Affairs with involvement in safety evaluation or risk communication

  • Safety-related regulatory affairs or post-marketing surveillance planning

• At least 3 years’ experience in safety management activities or similar duties, with experience in negotiation with regulators.

• Comprehensive knowledge of Japanese safety-related regulations (GVP/GPSP) is required; knowledge of worldwide regulations is desired.

• Ability to communicate with Japanese health authorities in Japanese.

• Strong strategic thinking, analytical, and problem-solving skills with good communication, presentation, and interpersonal skills.

• Experience within a global and multicultural environment and willingness to travel occasionally internationally.

Preferred Skills:

• Experience serving as Safety Management Manager (Anseki) or equivalent role.

• Experience interacting with PMDA.

• Experience in a pre-commercial or start-up pharmaceutical environment.

• Business-level English, Native level Japanese.

• Experience defining, building, and leading processes across a regional safety function to support cross-functional effectiveness and corporate partnership.

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