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About the Role
The Associate Director, Safety Science, Japan is responsible for providing safety science and pharmacovigilance expertise to safety management for assigned products within the RevMed portfolio in Japan. This role involves conducting safety signal detection and evaluation, contributing to clinical safety oversight, and leading the development and maintenance of Japan Risk Management Plans (J-RMPs) and other safety management activities in accordance with Japanese regulations, GVP/GPSP, company procedures, and global pharmacovigilance standards.
Responsibilities
- Conduct safety surveillance, signal detection, and scientific evaluation of safety information in alignment with global safety strategies and Japan specific requirements.
- Provide scientific input on Japan-specific safety considerations and contribute to the identification and evaluation of safety signals relevant to the Japanese patient population and clinical practice.
- Lead J-RMP development, maintenance, and implementation in collaboration with global and Japan stakeholders.
- Lead the preparation, review, and maintenance of the safety sections of Japanese Package Insert (J-PI) and other relevant product information.
- Collaborate with Japan and global stakeholders to assess safety concerns, support benefit-risk evaluation, and ensure alignment of safety information and activities across functions.
- Support clinical safety oversight through review and evaluation of clinical safety data and identification of emerging safety concerns.
Requirements
- At least 7 years of experience in pharmacovigilance or drug safety in Japan.
- At least 3 years of experience in the development and implementation of J-RMPs and J-PIs, including experience negotiating with Japanese health authorities (e.g. PMDA/MHLW).
- Comprehensive knowledge of Japanese safety-related regulations (GVP/GPSP) especially for J-RMPs and safety surveillance.
- Understanding of clinical safety concepts and ability to review and interpret clinical safety data.
- 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.
- Experience in clinical development, clinical trial operations, or clinical safety activities within the pharmaceutical industry.
- 2 years or more experience in Oncology drug development/post-marketing safety management activities.
Skills
- Safety Science
- Pharmacovigilance
- Safety Signal Detection
- Risk Management
- J-RMP Development
- J-PI Preparation
- Clinical Safety Oversight
- Benefit-Risk Assessment
- Collaboration
- Communication
Location
- Japan
Work Type
- Hybrid
Experience Level
- Associate Director
- 7+ years in pharmacovigilance/drug safety in Japan
- 3+ years in J-RMP/J-PI development and implementation
- 2+ years in Oncology drug development/post-marketing safety management (preferred)
Education Level
- Master’s degree, PhD, or equivalent advanced degree in a biological or medically related field
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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- 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.