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JOB SUMMARY

The Japan Case Management Lead is a member of the Japan PV Operations Leadership Team and reports to the Japan PV Operations Lead. He/She is responsible to implement and manage the case processing operation in Japan including case management for marketed and developing products, safety evaluation, PMDA reporting, Product Technical Complains (PTC) management of medical device/drug device combination products, PV inspection/audit and outsourcing vendor management.

He/She leads the Japanese safety management activities in close collaboration with PSPV, HA (Health Authorities), partner companies and other functions in compliance with global procedures and local regulatory PV requirements

■Responsibilities

1．Lead Japan case processing operation including of ICSR with pharma products/vaccine and PTC with medical device/drug device combination products

• Encourage improvement of case handling workflow for AE and PTC

• Review and improve/streamline case management process

• Case Management expert for all HA inspection inquiry and internal audit impacting JP case processing activities

• Closely work to lead the strategy with Case Management and Process team and Case Medical Safety team in CMME to execute global strategy into Japan case processing

• Align JP PTC reporting process to ROW in collaboration with Case Management Process &Device Oversight team in CMME

• Case Management expert leading all discussions involving internal/external stakeholder and Partner company about case management

2． Relevant outsourcing vendor management

• Responsible for overseeing the vendor’s activities and enhancing the quality of outsourcing vendors. As necessary, request CAPA, revise of related manuals and provide trainings to the external vendors. Monitor the daily vendor activities to improve the quality of the safety information to be entered into PV safety system.

• Give advice and feedback for the daily case management activities to outsourcing vendor such as Parexel Japan, India, and China

• Responsible to work jointly with the global case management team to align strategies in regards to vendor management

• Support successful and on time integrations and divestments impacting the Japanese portfolio

3. Relevant PV activities

• Oversight and execute the relevant PV activities and critical projects (ARTEMIS, METEOR, QualiPSO, etc.) with strong leadership in collaboration with Regional PV colleagues

• Promote efficiency of tasks of the entire team

KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS (Minimum requirements for assignment to this job)

Knowledge And Skills:

• Strong expertise in pharmacovigilance, clinical development, regulatory environment and requirements is a must

• Strong expertise in PTC regulations and PV safety systems including communication with HA

• Knowledge in periodic reports, safety evaluation and risk management

• High level of communication and management skills.

• Ability to analyze a complex situation and to take adequate measures and　decisions, in a constrained, evolving and challenging environment.

Ability to communicate verbally and in writing in English, to develop and support an argumentation in English.

Ability to provide a support to his/her collaborators.

Formal Education And Experience Required:

• Science degree with 5 or more years experience of pharmacovigilance/PTC management/post-marketing study/clinical development

• People management experience