Associate Director, Safety Operations, Japan

Revolution Medicines, Inc.; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Revolution Medicines, Inc. is seeking an Associate Director, Safety Operations, Japan to lead pharmacovigilance operations.

You will ensure timely, accurate safety information processing and reporting in collaboration with Global Patient Safety teams, CROs, and internal partners. Responsibilities include ICSR handling, data quality, aggregate reporting, PVAs, and Japan-specific pharmacovigilance activities in line with GVP/GPSP requirements and local procedures.

Qualifications

• Bachelor’s degree in healthcare or related field and strong pharmacovigilance experience.
• Minimum 7 years in pharmacovigilance/patient safety operations.
• Hands-on CRO/vendor management and regulatory compliance knowledge.
• Strong understanding of GVP/GPSP for clinical trials and post-marketing.
• Proficiency in developing pharmacovigilance procedures and workflows.

Responsibilities

• Coordinate and review ICSR processing, follow-up, and expedited reporting.
• Review safety data quality, reconciliation, and issue resolution.
• Coordinate periodic and aggregate safety reports for Japan.
• Manage Safety Agreements and PVAs and data exchange timelines.
• Oversee Japan pharmacovigilance operations per GVP/GPSP and local procedures.
• Coordinate audits, CAPA, and regulatory inspections readiness.
• Monitor CRO/vendor performance and drive corrective actions.
• Develop Japan-specific pharmacovigilance procedures and workflows.
• Coordinate pharmacovigilance training for staff and partners.

Skills

Pharmacovigilance

Safety reporting

CRO/vendor management

Regulatory compliance

Japanese proficiency

English proficiency

Education

Bachelor’s degree in healthcare

Master’s degree or higher

Job description

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 Operations , Japan is responsible for providing safety related operational expertise to safety management in Japan. The individual will be responsible for ensuring the timely, accurate, and compliant processing and management of safety information collection and reporting in collaboration with Global Patient Safety Operation team and other internal stakeholders, CROs, and other external partners.

Key Responsibilities:

• ICSR and Safety Reporting Operations: Coordinate and review ICSR processing, follow-up, case quality review, expedited reporting, ensuring timely and compliant execution.

• Safety Data Quality and Reconciliation: Review safety data quality and reconciliation activities, identify discrepancies or data quality issues, and coordinate appropriate follow-up and resolution.

• Aggregate Reporting: Coordinate and review periodic and aggregate safety reports in Japan, ensuring completeness, consistency, quality, and compliance with applicable requirements.

• Safety Agreements and Information Exchange: Coordinate the implementation and operational management of Safety Agreements and Pharmacovigilance Agreements (PVAs), including safety information exchange, agreed responsibilities, and reporting timelines.

• Japan Pharmacovigilance Operations: Coordinate and review Japan-specific pharmacovigilance operations in accordance with applicable GVP/GPSP requirements and local procedures, including post-marketing safety activities such as EPPV and RMP-related risk minimization measures.

• Compliance, Audit and Inspection Readiness: Coordinate self-inspections, internal audits, and regulatory inspections; identify and escalation operational and compliance issues; and follow up on CAPA implementation and issue resolution.

• Vendor Oversight: Monitor and review the quality, completeness, accuracy, and timeliness of pharmacovigilance activities and deliverables performed by CROs and other external partners, and follow up on identified issues and corrective actions.

• Process and Procedure Management: Develop and maintain Japan-specific pharmacovigilance procedures, work instructions, and operational workflows in alignment with applicable GVP/GPSP requirements, global processes, and local operational needs.

• Training and Competency: Coordinate and support pharmacovigilance training for relevant employees and external partners, and maintain appropriate training records in accordance with applicable requirements.

Required Skills, Experience and Education:

• Bachelor’s degree in a healthcare field.

• Minimum of 7 years of relevant experience in pharmacovigilance/patient safety operational activities.

• Hands-on experience working with CROs/vendors and management of external resources.

• Strong background in safety reporting regulatory compliance and safety reporting/regulations both for clinical trials and post-marketing.

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

• Ability to develop and maintain pharmacovigilance procedures, work instructions, and operational workflows in accordance with applicable requirements and global processes.

• Ability to identify operational and compliance issues, assess their impact, prioritize actions, and coordinate timely resolution.

• 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:

• Master’s Degree or higher in a healthcare field.

• Experience establishing or improving pharmacovigilance processes, procedures, work instructions, and operational workflows in a developing organization.

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 [e-mail].

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