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About the Role

The Associate Director, Safety Operations, Japan is responsible for providing safety-related operational expertise to safety management in Japan. The individual will ensure timely, accurate, and compliant processing and management of safety information collection and reporting in collaboration with global teams, CROs, and external partners.

Responsibilities

Coordinate and review ICSR processing, follow-up, case quality review, and expedited reporting, ensuring timely and compliant execution.
Review safety data quality and reconciliation activities, identify discrepancies or data quality issues, and coordinate appropriate follow-up and resolution.
Coordinate and review periodic and aggregate safety reports in Japan, ensuring completeness, consistency, quality, and compliance.
Coordinate the implementation and operational management of Safety Agreements and Pharmacovigilance Agreements (PVAs), including safety information exchange, agreed responsibilities, and reporting timelines.
Coordinate and review Japan-specific pharmacovigilance operations in accordance with applicable GVP/GPSP requirements and local procedures, including post-marketing safety activities.
Coordinate self-inspections, internal audits, and regulatory inspections; identify and escalate operational and compliance issues; and follow up on CAPA implementation and issue resolution.
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.
Develop and maintain Japan-specific pharmacovigilance procedures, work instructions, and operational workflows in alignment with applicable requirements and local needs.
Coordinate and support pharmacovigilance training for relevant employees and external partners, and maintain appropriate training records.

Requirements

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 for both 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.
Master’s Degree or higher in a healthcare field (Preferred).
Experience establishing or improving pharmacovigilance processes, procedures, work instructions, and operational workflows in a developing organization (Preferred).

Skills

Pharmacovigilance
Patient Safety Operations
Safety Reporting
Regulatory Compliance
GVP/GPSP
Vendor Management
Process Development
Auditing
Inspection Readiness
Training Coordination
Collaboration
Communication

Location

Japan

Work Type

Hybrid

Experience Level

Associate Director
7+ years

Education Level

Bachelor's degree in a healthcare field
Master's Degree or higher in a healthcare field (Preferred)

About the Company

Revolution Medicines is a global, commercial-stage 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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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.
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