[JDSU] Manager, Case Management / ケースマネジメント課長
Tokyo, Japan
5 日前

1 主な職務における成果責任 / Description of Primary Role & Responsibility

1)Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity

2) Carry out all case management activities as appropriate

3) Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

4) Ensure complete and timely forwarding of ICSR to Core

5) Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed

6) Consistently apply regulatory requirements and Pfizer policies

7) Analyze and monitor activities, define and implement corrective actions, where applicable

8) Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database

9) Provide oversight and team mentoring on case handling aspects, data extraction and analyses

10) Manage safety resources in the Case management 2

11) Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and / or project lead across the GPO DSU organization

12) Act as subject matter expert for the DSU within WWS

13) Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.

g., BUs, License Partners) regarding safety data collection and handling

14) Promote / participate, as appropriate, in local, internal and external safety activities

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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