[Quality] Safety Management Specialist-GVP [Heart Recovery]

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Chuo-ku, Tokyo, Japan

Job Description:

Job Responsibilities:

GVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan. He/she works at Tokyo Office closely and reports to Safety/GVP manager.

Principle Duties and Responsibilities:

• Creating and submitting adverse event reports to PMDA.
• Handling and assessing complaints and safety issues
• Maintaining and updating Japanese IFUs and user manuals
• Controlling documents, procedures, and records related to GVP and post-market activities.
• Collaborating with product assurance and post-market engineering teams in the US headquarters.
• Obtaining complaint investigation results from the US headquarters and creating customer letters.

Job Qualifications:

• Minimum 2 years of GVP and/or post-market engineering experience in the medical industries
• Good knowledge about GVP Ordinances and adverse event reporting
• Basic knowledge of Japan PMDA Act and QMS Ordinance
• English reading and writing skills (e.g., e-mail communication, translation of complaint information)
• Basic PC skills (Microsoft Excel, Word, PowerPoint, Access, Outlook)

• Preferred to have knowledge of cardiovascular related products
• Business level English communication skill

Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing