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Associate Director, PV Systems and Vendor Management
年収：
1200万 ～ 1700万
?
採用企業案件
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | Associate Director, PV Systems and Vendor Management |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【Position Summary】 The Associate Director, PV Systems and Vendor Management at Johnson & Johnson Innovative Medicine reports to the Country Safety Head, Local Medical Safety, Japan, and is responsible for leading the strategy, governance, and operational excellence of pharmacovigilance (PV) systems and vendor management. This role ensures that PV systems and outsourced activities are compliant, efficient, and inspection and audit readiness, in alignment with global standards and Japanese regulatory requirements (e.g., PMDA, GVP). The role is also responsible for budget and resource management for outsourcing, strategic outsourcing planning, and facilitating effective issue resolution between vendors and Local Medical Safety Japan. 【Essential Job Duties and Responsibilities】 １.Safety Systems Management ・Lead governance and lifecycle management of PV systems in alignment with Global Medical Safety (e.g., safety database and related IT systems/tools) ・Ensure compliance with global PV standards (GVP, GCP, Pharmaceuticals and Medical Devices Act, etc.) ・Oversee system validation, upgrades, and change control processes ・Collaborate with global teams for system harmonization and implementation of new tools ・Drive data integrity and inspection readiness Lead technical aspects of safety data migration or data transfer for MAH transfer projects. ２.Vendor Management ・Manage vendors supporting pharmacovigilance operation activities ・Lead selection, onboarding, and oversight of PV vendors (e.g., case processing, literature screening) in alignment with Global Medical Safety ・Establish and monitor KPIs, SLAs, and performance monitoring framework ・Ensure vendor compliance with regulatory and quality standards ・Manage escalation and issue resolution with vendors ・Oversee outsourcing budget and resource planning aligned with business needs ・Facilitate effective communication and issue resolution between vendor and Local Medical Safety Japan. ・undefined ３.Operational Excellence & Compliance ・Develop and optimize workflows to improve PV efficiency and quality in a technology aspect (e.g. AI and other technology tools in PV) ・Ensure timely and compliant ICSR reporting to health authorities in a PV system (e.g., PMDA) ・Support regulatory inspections and internal audits in a technical aspect (e.g., System verification of Database transfer) ・Lead CAPA implementation related to systems or vendor quality issues 4.Leadership & Stakeholder Management ・Lead and develop a team of system and vendor management professionals ・Develop talents in the group, using mentor, coach and train and evaluate them ・Assist the direct reports to exhibit their performance and provide opportunities for growth ・Act as a key liaison with global PV, IT, QA, and external partners ・Provide strategic input to LMS Japan Leadership Team ・Drive cross-functional collaboration (e.g., Regulatory, Clinical, Medical) |
| 労働条件 |
■勤務地： Chiyoda, Tokyo, Japan |
| 応募資格 |
【必須（MUST）】 ・Bachelor, Masteror other equivalent advanced degree in a biological or medically related field is required.・Minimum 8–10 years of experience in Pharmacovigilance y, with a minimum of 5 years of direct team management. ・Strong experience in PV systems (e.g., Argus, ArisG, LMSV) and vendor management ・In-depth knowledge of PV regulations (GVP, GCP, ICH guidelines, Pharmaceuticals and Medical Devices Act) Experience in regulatory inspections and audits ・Highly effective written, oral, and interpersonal communication skills in Japanese and Business-level English is required. ・Demonstrated ability to think strategically, lead through change and build teams. 【歓迎（WANT）】 ・Experience in global/matrix organization・Project management experience (system implementation or transformation) ・Knowledge of digital/automation tools (e.g., RPA, AI in PV) ・Vendor outsourcing/transition experience ・Knowledge of ICSR management |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2026/08/19 |
| 求人番号 | 9118448 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です