[Innovative Medicine] Associate Director, PV Systems and Vendor Management, Local Medical Safety, Ja

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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:

Position Summary

The Associate Director, PV Systems and Vendor Management at Johnson & Johnson Innovative Medicine reports to the Country Safety Head, Local Medical Safety, Japan, and is responsible for leading the strategy, governance, and operational excellence of pharmacovigilance (PV) systems and vendor management.
This role ensures that PV systems and outsourced activities are compliant, efficient, and inspection and audit readiness, in alignment with global standards and Japanese regulatory requirements (e.g., PMDA, GVP).

The role is also responsible for budget and resource management for outsourcing, strategic outsourcing planning, and facilitating effective issue resolution between vendors and Local Medical Safety Japan.

Essential Job Duties and Responsibilities

1.

Safety Systems Management


* Lead governance and lifecycle management of PV systems in alignment with Global Medical Safety (e.g., safety database and related IT systems/tools)


* Ensure compliance with global PV standards (GVP, GCP, Pharmaceuticals and Medical Devices Act, etc.)


* Oversee system validation, upgrades, and change control processes


* Collaborate with global teams for system harmonization and implementation of new tools


* Drive data integrity and inspection readiness


* Lead technical aspects of safety data migration or data transfer for MAH transfer projects.

2.

Vendor Management


* Manage vendors supporting pharmacovigilance operation activities


* Lead selection, onboarding, and oversight of PV vendors (e.g., case processing, literature screening) in alignment with Global Medical Safety


* Establish and monitor KPIs, SLAs, and performance monitoring framework


* Ensure vendor compliance with regulatory and quality standards


* Manage escalation and issue resolution with vendors


* Oversee outsourcing budget and resource planning aligned with business needs


* Facilitate effective communication and issue resolution between vendor and L...