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・R&D, Japan Patient Safety, Patient Safety Epidemiology and Evidence Generation / Director / プロジェクトマネージャー・事業企画・事業開発・研究・開発 2023年7月 〜 現在

Ο Established AstraZeneca K.K.'s first dedicated safety epidemiology function, building it into a multi-team organization of 20+ staff across epidemiology and two study-management teams, with end-to-end responsibility for all Japan post-marketing regulatory commitment studies, including database and primary-data-collection studies. Ο Forecasted multi-year demand based on regulatory and pipeline developments, designed the resulting organizational restructuring with HR, and now lead its implementation—refocusing the function on epidemiology, consolidating adjacent activities, and optimizing workforce and external-vendor costs. Ο Oversee a portfolio of 30+ post-marketing studies across all therapeutic areas (Oncology, CVRM, Respiratory & Immunology, Rare Disease), covering every AstraZeneca and Alexion product marketed in Japan. Ο Own department budget, FTE and workforce planning, talent development, and organizational capability building. Ο Safeguard study quality and integrity in four roles — approving authority, designated person responsible for post-marketing surveillance (製造販売後調査等管理責任者), epidemiologist, and lead reviewer of study protocols and reports. Ο Built a Quality-by-Design vendor selection and management model and standardized study processes in coordination with the global organization, ensuring cross-regional consistency and quality. Ο Established and now lead a 2024–2027 academic research collaboration with the Department of Pharmacoepidemiology, Kyoto University School of Public Health, applying advanced methods to RWD studies and strengthening internal epidemiologic research capabilities.

・Development & Medical, Medical Intelligence, Customer Group / Director / ディレクター・リサーチ・データ分析・業務プロセスコンサルタント 2023年3月 〜 2023年6月

Ο Led operational improvement of the medical information center, including redesign of its outsourcing model, development of a call-center quality framework, and strategic use of customer inquiry data.

・Global Pharmacovigilance, Autoimmune & Rare Disease Group / Director / プロジェクトマネージャー・コンプライアンス・研究・開発 2020年10月 〜 2023年3月

Ο Oversaw Japan and Asia lifecycle pharmacovigilance for 100 products in immunology, neurology, and psychiatry, including major immunomodulators (Infliximab, Fingolimod). Ο Led the Japan/Asia NDA for UPLIZNA® (Inebilizumab, NMOSD) and the Japan supplemental NDA for Valixa® (Valganciclovir, congenital cytomegalovirus), covering labeling, RMP, PMS, and database studies. Ο Led the cross-functional Japan re-examination of Infliximab and Fingolimod, spanning safety assessment, medical writing, regulatory communication, and GVP inspection. Ο Led a functional team of 9 dotted-line reports for pharmacoepidemiology and RWE generation, establishing a new operating model and process for PV database research. Ο Strengthened routine safety signal and risk management through RWD, partnering with major database vendors (RWD, MDV, JMDC) on epidemiological research and tooling. Ο Managed 9 direct reports across PV activities, risk management, PMS, and case processing, owning team development and the group budget.

・Drug Safety / Senior Manager / 業務プロセスコンサルタント・研究・開発・品質保証 2017年2月 〜 2020年9月

Ο Reduced the global post-marketing case management budget by ~70% year-over-year by proposing and managing its outsourcing to a vendor. Ο Built an end-to-end work breakdown structure and standard processes for clinical safety activities across the product lifecycle. Ο Authored and implemented a global Quality Management System (EU GVP Module I) including nonconformity reporting and CAPA — with a multi-regional team. Ο Authored the USFDA regulatory response on cardiovascular safety concerns arising from clinical and non-clinical studies. Ο Led drug safety process-improvement initiatives and coordinated cross-regional conferences for the global drug safety organization.

・Pharmacovigilance Manager / Pharmacovigilance Manager / リサーチ・データ分析・コンプライアンス・研究・開発 2015年10月 〜 2017年1月

Ο Developed the Risk Management Plan and NDA safety documentation (summary of safety, package insert) for CANALIA® Tablets (canagliflozin/teneligliptin FDC for T2DM). Ο Led PMDA consultation on the post-marketing commitment for CANALIA® and designed the post-marketing survey protocol to evaluate its safety and effectiveness. Ο Assessed the safety risk of teneligliptin (Pemphigus/Pemphigoid) across DPP-4 inhibitors by reviewing clinical and non-clinical data for causality and seriousness. Ο Authored responses to PMDA safety queries for 2 investigational and 1 marketed drug.

・Clinical Safety Manager / Clinical Safety Manager / リサーチ・データ分析・コンプライアンス・研究・開発 2011年10月 〜 2015年9月

Ο Supported risk-benefit assessment for a selective a7 nicotinic-receptor partial agonist (cognitive impairment), evaluating emerging Gl safety risks and running a weekly medical safety monitoring system built with the clinical team. Ο Developed a global ICSR-processing workflow across 5 partner companies compliant with US and Japanese regulatory requirements. Ο Liaised with PMDA and the US partner on emerging safety issues, and authored Clinical Safety SOPs and work instructions.

・Clinical Development / Assistant Manager / 研究・開発 2008年10月 〜 2011年9月

・CRA / CRA / 研究・開発 2007年10月 〜 2008年9月

・CRA / CRA / 研究・開発・品質管理 2004年1月 〜 2005年3月

Ο As a CRA, monitored 10+ clinical trials of TENERIA® (teneligliptin) and REMICADE® (infliximab) in type 2 diabetes and autoimmune diseases (Behcet's disease, ulcerative colitis, rheumatoid arthritis), conducting site visits to 50+ sites to ensure protocol compliance and data quality. Ο Oversaw centralized site management and CRO monitoring for a pivotal trial, and authored portions of clinical study reports and CTDs.

・Research Associate / Research Associate / 研究・開発・生産技術・製造技術・品質管理 2003年4月 〜 2003年12月

Ο Performed production tests and purity analyses to improve the manufacturing process for recombinant Human Serum Albumin (rHSA), and produced investigational rHSA injections for clinical studies.