[MedTech] Medical Device Safety/ Pharmacovigilance Specialist, 安全管理部 (Surgery Commercial Quality)

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Job Function:

Product Safety

Job Sub Function:

Pharmacovigilance

Job Category:

Scientific/Technology

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Johnson and Johnson MedTech, Commercial Qualityにおける安全管理部（Vigilance Safety）にてSurgeryグループのスタッフを募集します。

主に製造販売後安全管理業務に関する手順に基づく業務（実施と説明責任）を担当します。

国内外の関連規制および企業のコンプライアンスを遵守するための、関連法規、Globalおよび社内規定等に従って、担当製品（医療機器、医薬品、またはその両方）の顧客苦情、有害事象、副作用等を含む安全管理情報の収集、評価、措置の立案および実施を遂行するとともに潜在的な安全性の問題の特定や安全対策、適正使用の施策対応に貢献していただきます。

主要な責務

不具合報告/副作用報告：

• 安全管理情報の評価の最終化と規制当局（PMDA）への報告。市場における有害事象発生状況のモニタリングと対策の検討・実施。
• 担当製品に関連する安全管理情報（国内外の症例や文献、海外における措置情報等）の情報収集プロセスの構築と維持。

安全確保措置と適正使用の推進：

• 必要な安全対策の立案。
• 新製品導入、製品変更時を含むリスクマネジメント活動の参画。
• 添付文書、取扱説明書の作成/改訂。
• 添付文書作成及び改訂に関する交渉と合意形成（海外製造元、PMDA） 適正使用推進のための施策立案と実行。

コンプライアンスの遵守と継続的改善：

• 関連手順や規制に関する必要なトレーニングの受講とその遵守。
• GVP関連トレーニングの提供。
• 査察におけるデータの提示、説明など。
• AIやデジタルツールを活用した安全管理業務の効率化・高度化およびプロセス改善の推進。
  

学歴

大学卒業（Health Scienceまたはその他関連分野の学士号または同等の経験があれば尚良し）

経験とスキル：

必須：

• セルフマネジメント：チャレンジングなスケジュール下でも、的確に優先順位付けし、計画的・効率的に業務を行う能力。
• 自主性を高くもちながら、他の人と協力して作業する能力。
• プロアクティブなアプローチ/独自のイニシアチブを適切に発揮できる。
• 課題発見、論理的思考、意思決定、問題解決スキル。
• 目標達成に対する強いコミットメント及び柔軟性のある実行力。
• 前向きな姿勢。
  

Preferable：

• 担当領域における製品知識、業務経験。
• 医療機器、製薬業界での経験、または医療従事者としての実務経験。
• 安全管理部門（Pharmacovigilance業務も含む）、マーケティング部、営業部、薬事部や品質保証部での経験。
• 日本語での口頭および文書による優れたコミュニケーション能力。
• ビジネスレベルの英語。
• デジタル技術・サービスに関する知識や経験、ITリテラシー。

その他：

勤務形態：J&J Flexに準ずる。

Vigilance/Safety of Commercial Quality in Johnson and Johnson MedTech is recruiting for an Surgery group staff, located in Tokyo HQ office.

Responsible for actual practice (implementation and accountability) of safety control procedures. Responsibilities include collection, evaluation and planning/implementing safety assurance measures in responsible therapeutic area (medical devices, pharmaceuticals, or both), following company standard operating procedures (SOPs), internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies, and to contribute to identifying potential safety issues.

Key Responsibilities:

Case processing (Medical devices and/or Pharmaceuticals):

• Make a final safety assessment of collected information for decisions in Seriousness, expectedness and causality of safety information with due date for reporting to Health Authority (PMDA). Monitor and manage the adverse event occurrence. Make report to PMDA.
• Develop and maintain safety process with stakeholders such as spontaneous report, literature cases (Japanese article, foreign article) and foreign cases.

Safety assurance measures and acceleration of proper use:

• Plan necessity of safety measure.
• Participate in product risk management including NPI and change control.
• Generate and revise package insert and user manual for the responsible product.
• Negotiation between JJKK and operating company and/or PMDA about package insert. Planning and implementation of measures to promote proper use.

Compliance & continuous improvement:

• Complete Training of Local and global SOPs and guidelines, Relevant Japanese regulations and compliance with the requirements.
• Provide GVP-related training.
• Participate in inspections and audits including provision of requested data.
• Promoting the streamlining, sophistication, and process improvement of safety management operations through the use of AI and digital tools.

Education:

Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).

Experience and Skills:

Required:

• Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines.
• Ability to work both independently and in collaboration with others.
• Proactive approach/uses own initiative appropriately.
• Logical thinking, Decision-making and problem-solving skills Strong commitment to achieving goals and flexible execution capability.
• Positive attitude.

Preferred:

• Knowledge of Surgery products.
• Experience in the medical device or pharmaceutical industry, or clinical experience as a healthcare professional.
• Experience in Vigilance (including Pharmacovigilance), Marketing, Regulatory Affairs, Quality Assurance or experience as a sales representative.
• Good verbal and written communication skills in Japanese.
• English in business level.

Other:

• Work style based on J&J flex.

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Operations, Collaboration, Cross-Functional Collaboration, Detail-Oriented, Execution Focus, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy