Director, ReveMate and PPP

Division Research and Development / Worldwide Patient Safety / International Patient Safety/Patient Safety Japan Functional Area Description The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. Position Summary This role provides strategic leadership in the effective management of the RevMate Pregnancy Prevention program (PPP) for IMiD products and the design and implementation of PPP risk minimization measures for any future assets, where required. As a member of the Patient Safety Japan (PSJ) Leadership Team, drives organization change and development of the team and represents PSJ across the organization through strong cross‑functional partnerships. Key Activities
To ensure the benefit-risk balance across the product lifecycle remains favorable for the relevant products by executing appropriate safety measures in line with MHLW-agreed requirements. To ensure the structure, performance and effective oversight of the end-to-end operations of RevMate for post marketing IMiD products and future Pregnancy Prevention Programs (PPP) for additional assets in Japan are effective, robust and efficient. Leads a team of several members and manages vendors involved in the execution of the PPP. To contribute to R&D activities and drive implementation strategies to design and implement future PPPs for investigational assets that include this requirement. To communicate and collaborate effectively with internal and external stakeholders to ensure effective management and governance of the PPPs and close collaboration to achieve the program’s intended objectives. To ensure excellent regulatory compliance and credibility with MHLW, PMDA, HCPs, patients and other associations.
Position Responsibilities Risk Minimization of IMiD/CELMoD Products (PPP)
Ensure the required revisions of RevMate at appropriate timings. Ensures the activities of RevMate center to comply RevMate. Ensures the implementation of required education to comply RevMate. Supervises the required audits to comply RevMate. Supervises the activities of on‑site workers to comply RevMate. Ensures the operation of RevMate steering committee to comply RevMate. Ensures the effective communication with internal stakeholders like Soseli, Anseki, Brand team, Compliance, Legal and etc. Ensures the appropriate communications with external organizations associated with RevMate (the 3rd party evaluation committee, MHLW, etc). Ensures development of PPP documents for clinical studies.
Cross‑Functional Collaboration
Supports the clinical study team from safety perspective. Trains staff on product safety profile and risk minimization measures. Lead the cross‑functional team in the event of changes, deviations or improvements being required for a PPP to assess impact, drive decision making and ensure effective implementation. Frequently interacts with global teams (including Global Risk Management, Safety Management Teams, WWPS IT) to drive implementation strategies and ensures full alignment and utilization of global resources and expertise.
Safety Control Activities / Compliance
Ensures the awareness of the changes in regulations and evaluates the impact on local processes. Ensures the appropriate safety vigilance procedure and in interactions with other department and Global Drug Safety and Risk Management (GDSRM).
Degree Requirements
University degree. Fluent in Japanese and English with ability to work in global context.
Required Experience
Ten (10) years pharmaceutical/biotechnology industry experience. Five (5) years management experience. Project management experience preferred.
Required Knowledge
Global / local Pharmacovigilance/safety regulatory requirement (Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations, GCP, GVP, GPSP, etc.). Pharmaceutical and Science background preferred.
Key Competency Requirements
People management skill. Group Leadership. Negotiation/ cross-functional collaboration skill. Presentation skills. Resource and vendor management.
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