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Tailor your resume to this [MedTech] Medical Device Safety/ Pharmacovigilance Specialist, 安全管理部 (Surgery Commercial Quality) role.

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About the Role

Johnson and Johnson MedTech, Commercial Quality is seeking a Staff member for the Vigilance Safety department within the Surgery group. This role is responsible for executing and overseeing safety control procedures for medical devices and/or pharmaceuticals, ensuring compliance with global regulations and corporate policies. The position contributes to identifying potential safety issues and implementing safety assurance measures.

Responsibilities

Perform final safety assessments of collected information for seriousness, expectedness, and causality.
Report safety information to the Health Authority (PMDA).
Monitor and manage adverse event occurrences.
Develop and maintain safety processes with stakeholders, including spontaneous reports, literature cases, and foreign cases.
Plan necessary safety measures.
Participate in risk management activities, including new product introductions and change controls.
Generate and revise package inserts and user manuals.
Negotiate package insert content with JJKK, operating companies, and/or PMDA.
Plan and implement measures to promote proper use of products.
Complete training on local and global SOPs, guidelines, and relevant Japanese regulations.
Provide GVP-related training.
Participate in inspections and audits, including providing requested data.
Promote streamlining, sophistication, and process improvement of safety management operations using AI and digital tools.

Requirements

Ability to prioritize, plan, and organize work assignments under strict timelines.
Ability to work both independently and collaboratively.
Proactive approach and ability to use initiative appropriately.
Logical thinking, decision-making, and problem-solving skills.
Strong commitment to achieving goals and flexible execution capability.
Positive attitude.
Good verbal and written communication skills in Japanese.
Business-level English proficiency.

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
Product knowledge in the Surgery domain (preferred)
Experience in the medical device or pharmaceutical industry (preferred)
Clinical experience as a healthcare professional (preferred)
Experience in Vigilance (including Pharmacovigilance), Marketing, Regulatory Affairs, Quality Assurance, or sales (preferred)
Knowledge and experience with digital technologies and services (preferred)
IT literacy (preferred)

Location

Chiyoda, Tokyo, Japan

Work Type

J&J Flex

Education Level

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

About the Company

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. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.