Associate Director, Safety Science, Japan

Revolution Medicines, Inc.; United States; On-site; USD 126,000 - 190,000; Full time

Job summary

Revolution Medicines seeks an Associate Director, Safety Science, Japan to provide safety science and pharmacovigilance oversight for the RevMed portfolio in Japan. You will lead safety signal detection, J-RMP development, and J-PI safety labeling while aligning with GVP/GPSP standards and global safety strategies.

You will work with Global Safety, Clinical Development, Regulatory Affairs, and cross-functional teams to ensure timely, scientifically sound safety decisions supporting patient

Qualifications

• Master's degree, PhD, or other equivalent advanced degree in a biological or medically related field.
• 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.
• Business-level English and native-level Japanese proficiency.
• Experience within a global and multicultural environment.

Responsibilities

• Safety Surveillance: conduct safety surveillance, signal detection, and scientific evaluation of safety information.
• Lead J-RMP development, maintenance, and implementation with global and Japan stakeholders.
• Lead the safety sections of Japanese Package Insert (J-PI) and other product information updates.
• Collaborate with Japan and global stakeholders to assess safety concerns and ensure alignment of safety information.
• Support clinical safety oversight through review of clinical safety data and collaboration with Global Safety Scientist and Clinical Development teams.

Skills

Pharmacovigilance

Safety signal detection

Cross-functional collaboration

Communication skills

English proficiency

Japanese proficiency

Education

Master's degree or PhD in biological/medical field

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 Science, Japan is responsible for providing safety science and pharmacovigilance expertise to safety management with the assigned products across the RevMed portfolio in Japan. The individual will be responsible for conducting safety signal detection and evaluation, contribution to clinical safety oversight, and leading development and maintenance of Japan Risk Management Plans (J-RMPs), and other safety management activities in accordance with applicable Japanese regulations, such as GVP/GPSP, company procedures, and global pharmacovigilance/patient safety standards.

The Associate Director, Safety Science works closely with the Global Safety Science team and other Global/Japan Safety Functions, Clinical Development, Regulatory Affairs, Medical Affairs, and cross-functional stakeholders to ensure timely, scientifically sound, and compliant safety decisions that support patient safety and the benefit-risk assessment of the assigned products.

Key Responsibilities

• Safety Science: Conduct safety surveillance, signal detection, and scientific evaluation of safety information in alignment with global safety strategies and Japan specific requirements if any. 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.




• Risk Management: Lead J-RMP development, maintenance, and implementation in collaboration with global and Japan stakeholders to ensure alignment between global risk management strategies and Japan-specific regulatory requirements and safety considerations.




• Safety Labeling & Product Information: Lead the preparation, review, and maintenance of the safety sections of Japanese Package Insert (J-PI) and other relevant product information, ensuring alignment with the Company Core Data Sheet, global safety information, and applicable Japanese regulatory requirements.




• Cross-functional Collaboration: Collaborate with Japan and global stakeholders to assess safety concerns, support benefit-risk evaluation, and ensure alignment of safety information and activities across functions.




• Clinical Safety: Support clinical safety oversight through review and evaluation of clinical safety data and identification of emerging safety concerns in collaboration with Global Safety Scientist and Clinical Development teams.

Required Skills, Experience and Education

• A master’s degree, PhD, or other equivalent advanced degree in a biological or medically related field is required.




• 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 negotiatiing with Japanese health authorities (e.g. PMDA/MHLW).




• Comprehensive knowledge of Japanese safety-related regulations (GVP/GPSP) especially for J-RMPs and safety surveillance is required.




• 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.

Preferred Skills

• 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.

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