[MedTech] Vigilance Safety Staff(Orthopaedics

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 (mainly Joint), 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:

• Make a final safety assessment of collected information for decisions in Seriousness,

expectedness and causality of safety information with due date for reporting to 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.

• Continuous improvement of GVP process including usage of 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 Joint reconstruction products.

Medical device or pharmaceutical industry

experience

• Experience in Vigilance, Marketing, Regulatory Affairs, Quality Assurance or experience

as a sales representative.

• Knowledge or experience of Digital technology and service

Other:

• Work style based on J&J flex

• Good verbal and written communication skills in Japanese

• English in business level

• Good IT literacy