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[Innovative Medicine] Country Safety Head Japan （Director Pharmacovigilance）, Japan Local Safety Unit
年収：応相談
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 | [Innovative Medicine] Country Safety Head Japan （Director Pharmacovigilance）, Japan Local Safety Unit |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
■Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. ■Job Description: The Country Safety Head is responsible and accountable for ensuring all pharmacovigilance requirements for Johnson & Johnson Innovative Medicine is fulfilled. Provides strategic leadership to the teams to ensure and enable the achievement of the overall strategic imperatives of Local Medical Safety (LMS) in Japan. Essential Job Duties and Responsibilities Ensure patient safety and product safety for entire Johnson & Johnson Innovative Medicine products. - Accountable for the compliance of the Pharmacovigilance activities including safety information intake & reporting to GMS/PMDA, PV agreements with business partner/vendor, and Risk Management Plan. - Accountable for all GVP-related activities, either directly or through deputization, including activities such as: Development and implementation of Japan Risk Management Plan (J-RMP), conducting Early Post-marketing Phase Vigilance (EPPV), analysis of safety information, and monitoring of benefit risk balance Launch readiness of the products from safety aspects before approval of (supplemental) J-NDA Maintaining favorable benefit-risk balance of the marketed products, with timely communication of relevant safety information available to Health Care Professionals Planning proper safety measures, decide to implement the plan or make proposals on the plan to the Marketing Supervisor-General depending on the definition of the measure in the procedural documents Implementation and monitoring of risk management plans and take the appropriate actions for the implementation if urgent safety restrictions, as required. Ensuring GVP requirements and all updates are reflected in the procedural documents and put in place. - Oversight Japan Product Safety Committee (JPSC) - Build the strong communication and work closely with relevant stakeholders such as Marketing Supervisor-General, Quality Assurance Manager, PMS Control Manager, Head of Medical Affairs, Safety Operational Organization like Business Unit and partner companies. Leadership and strategic direction of all activities in Japan Local Safety Unit (J-LSU) - Provide strategic leadership and vision for J-LSU - Strengthen organizational development such as such as building a high-performance & engaged team through effective change management and fostering an inclusive culture, to enable achievement of strategy and vision. - Direct and has oversight of all Japan safety processes and activities through a professional management staff of Senior Managers and Managers. - Ensure robust hiring of qualified staff for the Unit, with optimal resource management and prioritization across the Unit. Responsible for supporting talent development and providing opportunities for growth. As a member of the APAC LMS Leadership Team, - Contribute to developing and driving the mission and vision of APAC LMS, through active engagement in regional safety initiatives and projects - Establish strong relationships with regional stakeholders. - Deputies for Regional Safety Head if required |
| 応募資格 |
【必須（MUST）】 Bachelor, Master, PhD or other equivalent advanced degree in a biological or medically related field is required, and MD is preferable.At least 10 years or more experience in the pharmaceutical industry, with a minimum of 5 years of direct team management, preferably of large teams. At least 3 years’ experience in safety management activities or similar duties, with experience of negotiation skills with regulators Comprehensive Knowledge of Japan PV regulations is required; knowledge of worldwide regulations is desired Highly effective written, oral, and interpersonal communication skills in Japanese and fluency in English is required Demonstrated ability to think strategically, lead through change and build teams. Demonstrated innovative thinking to allow for optimal design and implementation of global safety strategies. Must have strong managerial, influencing and communication skills necessary to act as a liaison with other disciplines and outside organizations. Experience in a cross cultural/global environment necessary. |
| 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 | 2025/10/23 |
| 求人番号 | 5943807 |
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