Safety Management Specialist

Job description

JOB DESCRIPTION:

Position

This is the position of Safety Management Specialist at the Commercial Quality Abbott Diagnostics Medical Co., Ltd.

This position is so called “Anseki” to deploy and implement post marketing surveillance according to the GVP (Good Vigilance Practice) regulations, which is required by the Japanese Pharmaceutical Law.

Job Description

This position is required the following roles and responsibilities.

· 
Deploy and monitor post marketing surveillance requirements in accordance with the Japanese pharmaceutical regulations and Abbott Quality Standards in the local commercial organization.

· 
Audit and Inspection readiness support and remediation of the audit related corrective actions from GVP perspectives.

· 
Monitor and judge for escalated complaints whether or not to be reportable to the Japan authority and Abbott global as PRE (Potentially Reportable Event) .

· 
Quality Incident/CAPA/Document control and implementation.

· 
Implementation of Management Review from GVP view-points on quarterly basis.

· 
Implementation of GVP trainings for Abbott Diagnostics Medical Co., Ltd. organization, distributors and 3dr party Logistics as well.

Experience

More than a three -year experience of GVP activities related to pharmaceutical, IVD, Medical Device industries.

Knowledge and Skill

· 
GVP/QMS ordinance or related regulations, e.g. ISO 13485

· 
Communication, discussion and negotiation skills with local authorities PMDA, MHLW, and Abbott global organizations.

· 
English skills to read and write vigilance documents

Location

Shinjuku office (7F SHINJUKU NS Bldg. 2-4-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo)

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDDM ARDx Infectious Disease Developed Markets

        

LOCATION:

Japan > Shinjuku-ku : 2-4-1 Nishi-Shinjuku

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable