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About the Role

The Associate Director, Safety Systems, Japan is responsible for providing safety and pharmacovigilance systems expertise to support safety management activities in Japan. This role ensures 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.

Responsibilities

Coordinate with Global Safety Systems and relevant global functions to ensure the effective use of global safety databases and related pharmacovigilance systems in Japan.
Manage Japan-specific system administration activities, including user access, user roles, local workflows, and other administrative tasks.
Monitor system data integrity and system controls for Japan operations; identify discrepancies or system-related issues and coordinate appropriate investigation and resolution.
Coordinate Japan-specific business and regulatory requirements for system changes, enhancements, releases, and configuration updates.
Support system validation, periodic reviews, change control, and related compliance activities.
Coordinate the investigation, documentation, escalation, and resolution of system incidents, defects, and operational issues affecting Japan operations.
Monitor and review system support and deliverables provided by system vendors, CROs, and other external service providers.
Develop and maintain Japan-specific safety system procedures, work instructions, and operational documentation.
Coordinate and support system-related training, user guidance, and ongoing support for Japan users and relevant external partners.
Support audits and regulatory inspections by ensuring the availability, completeness, and consistency of Japan-specific system documentation, records, and validation evidence.

Requirements

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.

Skills

Safety System Operations
Global Coordination
Local System Administration
User Access Management
System Data Quality
System Controls
System Validation
Compliance
System Issue Management
Incident Management
Vendor Oversight
Process Management
Documentation Management
Training
User Support
Audit Readiness
Inspection Readiness
Safety One Argus
Empirica Signal
Spotfire
Oracle Analytics Server

Location

Japan

Work Type

Hybrid

Experience Level

Associate Director
7 years of experience

Education Level

Bachelor’s degree in a scientific, technical, or related field
Advanced degree is preferred

About the Company

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.

Equal Opportunity

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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 careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.