GVP MANAGER
Category | QC/QA (GMP, GQP, QMS, GVP) | Salary | 6 - 9 M¥ |
Work Type | Permanent | Date | 2011-01-21 |
Location | Tokyo | Ref.# | CBRET 2955331 |
Overview
GVP Mngr role with medical company.
Company Description
Mid-sized, foreign medical device company with a growing share in the Japanese market.
Responsibilities
PART I - POSITION SUMMARY
For the purpose of Product Safety Management and Risk Management, he/she must all responsibilities for our product complaints from our customers through our sales personnel and dealers. Under control of MAH General Manager, he/she must report any accidents/incidents to authorities, MHLW, PMDA and Local Government, especially Tokyo Metropolitan Government.
PART II - PRINCIPAL RESPONSIBILITIES
1. Manage PPG Specialist and PPG Analyst regarding product performance.
2. Communicate with Authorities, MHLW, PMDA, TMG etc. regarding Safety & Risk Management activities of the company.
3. Has all responsibilities for customer letters regarding complaints & returned products.
4. Analyze customer complaints and find out the systematic errors of our products.
5. Report to MAH General Manager by documents about systematic errors of our products.
6. Initiate N/C & CAPA to AI Headquarter in Reading.
7. Communicate with responsible person in hospital and explain to use our products properly.
8. Advise and revise our product insert sheer (Tenpu-Bunsho) according to authorities requests.
9. Adhere to and ensure the compliance of the company's code of Conduct, all Company policies, rules, procedures and housekeeping standards.
Requirements
- Bachelor of Science in university.
- At least 3 years experiences of complaints handling in Call Center or Quality Assurance division.
- CPU skills - Word, Excel and PPT etc.
Preferred Experience
- Strong clinical knowledge
Desired Traits
- Communication skill for dealing with doctors
Description of Benefits
* Holidays: Paid vacation
Additional Notes
GVP MANAGER