[Innovative Medicine] Manager, Case Management, Local Medical Safety, Japan

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Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

JOB SUMMARY:

• Leads operational management of a Case Management Group consisting of individual contributors, implements operational plans with adequate business purpose, and is accountable for ensuring efficient, compliant, high-quality, timely case management operations while optimizing resource utilization and operational throughput.

• Communicates and builds effective relationships with relevant stakeholders outside LMS Japan, including global and regional stakeholders as appropriate, to provide vision, strategic direction and/or alignments in the case management and stakeholders.

KEY RESPONSIBILITIES:

1.

Ensure the quality of outputs related to case processing activities and maintain compliance with applicable timelines.


* Control the quality of outputs provided to PMDA, Global Medical Safety (GMS), Local Medical Safety (LMS), and other groups for safety-related activities, including but not limited to aggregate reports, risk management plans, and safety information distribution to healthcare professionals (HCPs).

Lead kinds of implementation plan in case management and improvement with the risk-based approach.


* Control compliance with timelines for PMDA reporting and headquarters reporting in the case management group.

Escalate compliance risks with potential countermeasures to supervisors and stakeholders.


* Monitor the quality and compliance of the adverse event (AE) reporting process.

Plan and take appropriate countermeasures with alignment in stakeholders as needed.


* Establish more efficient and reliable case processing in accordance with business requirements, including the utilization of outsourcing where appropriate.


* Evaluate the impact of new SOPs and related regulations, and implement new or revised processes with alignment in stakeholders as needed.


* Handle internal audits and external inspections related to case processing such as investigation (root cause analysis), proposing corrective/preventive action, alignment wit...