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Open nowPosted 6 hours ago

Associate Director, Safety Systems, Japan

Revolution Medicines269 open roles

Where
Tokyo, Japan
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Your applicationOpen nowAssociate Director, Safety Systems, JapanRevolution Medicines · Tokyo, Japan
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The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market. Revolution Medicines postings stay open a median of 29 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 6 hours ago

Revolution Medicines median: 29 days open

The posting

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

The Associate Director, Safety Systems, Japan is responsible for providing safety and pharmacovigilance systems expertise to support safety management activities in Japan. The individual will be responsible for ensuring the effective operation and local use of global safety databases and related pharmacovigilance systems, coordinating Japan-specific system requirements and changes, and ensuring appropriate system administration, data quality, documentation, and user support in accordance with applicable Japanese regulations such as GVP/GPSP, company procedures, and global pharmacovigilance/patient safety standards.

The Associate Director, Safety Systems works closely with Global Safety Systems, Global IT, and other Global/Japan Safety Functions and cross-functional stakeholders to ensure the reliable, compliant, and effective use of safety systems in Japan. The individual also coordinates with CROs, system vendors, and other external partners, supporting system issue resolution, validation and change activities, audit and inspection readiness, and continuous improvement of local safety system operations.

Key Responsibilities:

  • Safety System Operations and Global Coordination: Coordinate with Global Safety Systems and relevant global functions to ensure the effective use of global safety databases and related pharmacovigilance systems in Japan.
  • Local System Administration and User Access: Manage Japan-specific system administration activities, including user access, user roles, local workflows, and other administrative tasks in accordance with approved procedures and global standards.
  • System Data Quality and Controls: Monitor system data integrity and system controls for Japan operations; identify discrepancies or system-related issues and coordinate appropriate investigation and resolution.
  • Local Requirements and System Changes: Coordinate Japan-specific business and regulatory requirements for system changes, enhancements, releases, and configuration updates with Global Safety Systems and relevant stakeholders.
  • System Validation and Compliance: Support system validation, periodic reviews, change control, and related compliance activities in accordance with applicable GVP/GPSP requirements, global procedures, and computer system validation principles.
  • System Issue and Incident Management: Coordinate the investigation, documentation, escalation, and resolution of system incidents, defects, and operational issues affecting Japan operations.
  • Vendor and System Provider Oversight: Monitor and review system support and deliverables provided by system vendors, CROs, and other external service providers, and follow up on identified issues and agreed actions.
  • Process and Documentation Management: Develop and maintain Japan-specific safety system procedures, work instructions, and operational documentation in alignment with global processes and applicable local requirements.
  • Training and User Support: Coordinate and support system-related training, user guidance, and ongoing support for Japan users and relevant external partners.
  • Audit and Inspection Readiness: Support audits and regulatory inspections by ensuring the availability, completeness, and consistency of Japan-specific system documentation, records, and validation evidence.

Required Skills, Experience and Education:

  • Bachelor’s degree in a scientific, technical, or related field is required
  • At least 7 years of experience in pharmacovigilance systems, safety operations, or related technical domains
  • Experience supporting system changes, releases, enhancements, incidents, defects, or other system-related operational issues.
  • Solid knowledge of safety databases and related pharmacovigilance systems, including system workflows, user access, data controls, and system operations.
  • Understanding of pharmacovigilance processes and applicable Japan GVP/GPSP requirements, particularly system-related requirements.
  • Strong collaboration and communication skills, with the ability to work effectively with internal stakeholders, global safety teams, CROs, and other external partners.
  • Strong learning orientation, curiosity, and commitment to science and patients.
  • Business-level English and native-level Japanese proficiency.
  • Experience within a global and multicultural environment.

Preferred Skills:

  • Advanced degree is preferred
  • Hands‑on expertise with safety databases and analytics platforms (e.g., Safety One Argus, Empirica Signal, Spotfire, Oracle Analytics Server)

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].

#LI-RY1 #LI-Hybrid

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.

Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.

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