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

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