[Quality] Safety Management Specialist-GVP [Heart Recovery]
AI in this role
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.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Chuo-ku, Tokyo, JapanJob 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:
<Requirements>
- 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)
<Preferences >
- 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 WritingHow we score this
[Quality] Safety Management Specialist-GVP [Heart Recovery] at Johnson & Johnson scores 34 out of 100 on AI centrality, which makes it AI Level 1 of 4 (Little AI) on this board. The level measures how much of the work is AI, not seniority.
AI Level 1. The work itself involves no AI, or AI only appears as scenery, such as a company tagline.
- AI Level 480 to 100
- AI Level 360 to 79
- AI Level 240 to 59
- AI Level 10 to 39
Bands come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.
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