Japan Risk Management Leader

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Job details

Company overview

Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.

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