Japan Risk Management Leader

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Job details

Company overview

Our client is developing and providing various medicines for an array of health concerns.

Responsibilities

• ake full accountability to create, implement and verify J-RMP activities including EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices and all activities related to Post-Marketing Surveillance/Clinical study/Database research.
• Take full accountability to prepare Re-examination dossier and GPSP compliance inspection in responsible products/compounds.
• Lead and manage PvA and PMSO in responsible products/compounds.
• Lead and facilitate J-SMT meeting in collaboration with JPKK’s key stakeholders including JCoT members.
• As an extended member of Global Safety Management Team(G-SMT), liaise with G-SMT of responsible products/compounds.Join JCoT, NPI and other related committee with license partner companies as a representative for J-SMT of responsible products/compounds and proactively lead safety risk management related discussions and take necessary actions by covering early stage of clinical development though postmarketed phase of products.
• Lead and contribute to the prevention and rapid resolution of local safety risk management related issues including timely stake holder management (internal and external) of responsible products/compounds.
• Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with Group manager/ Director.
• Contribute to the implementation of continuous process improvements from advanced safety management point of view by utilizing latest technologyes while enhance sustainable efficiency in collaboration wih SPMD.
• Understand the rule and principle of the relevant regulations such as PMD Act., GCP, GVP and GPSP and ensure compliance to those regulations, within own responsibility.

Requirements

Experience/Knowledge:

• 8-year or more experiences in pharmaceutical industries are generally recommended.
• Scientific & medical knowledge including local regulations, GCP, GVP & GPSP.

Skills/Capabilities:

• Must have strong leadership including decision making, management, negotiation, and stakeholder management and communication skills necessary.
• Ability/competency to show contentious proposals to responsible teams and groups including JCoT.
• English communication skill (TOEIC 700 point and above), verbal, writing, presenting and facilitating.

Salary

9 - 14 million yen

Location

Tokyo