Associate Director, Safety Science, Japan
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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