[Quality] Safety Management Specialist-GVP [Heart Recovery]
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
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:
- 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 WritingRequired Experience:
IC
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
