Compliance Specialist 2

求人内容

Primary Function of Position:
The Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complaint

handling filings. Maintain post marketing and complaint handling documentation with necessary filings

and communications to appropriate parties. Communicate with government / regulatory agencies on a

local basis. Support the quality management activity in cooperation with QA team. Prepare and

maintain SOP for post-marketing filing, complaint handling and quality management.

資格

Roles and Responsibilities:

 Preparation and implementation of GVP in compliance with Japanese PAL.

 Collection and first reviewer of local and overseas post-marketing safety information.

 Complaint handling management for filings and prepare the customer letter.

 Communication with head office on complaint cases for preparation of customer le...