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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 Local Medical Safety Japan.

3. Operational Excellence & Compliance

• Develop and optimize workflows to improve PV efficiency and quality in a technology aspect (e.g. AI and other technology tools in PV)
• Ensure timely and compliant ICSR reporting to health authorities in a PV system (e.g., PMDA)
• Support regulatory inspections and internal audits in a technical aspect (e.g., System verification of Database transfer)
• Lead CAPA implementation related to systems or vendor quality issues

4. Leadership & Stakeholder Management

• Lead and develop a team of system and vendor management professionals
• Develop talents in the group, using mentor, coach and train and evaluate them
• Assist the direct reports to exhibit their performance and provide opportunities for growth
• Act as a key liaison with global PV, IT, QA, and external partners
• Provide strategic input to LMS Japan Leadership Team
• Drive cross-functional collaboration (e.g., Regulatory, Clinical, Medical)

Minimum Qualification Required

• Bachelor, Masteror other equivalent advanced degree in a biological or medically related field is required.
• Minimum 5–8 years of experience in Pharmacovigilance, with a minimum of 2 years in case management desired
• Minimum of 3 years of direct team management.
• Strong experience in PV systems (e.g., Argus, ArisG, LSMV) and vendor management is desired
• In-depth knowledge of PV regulations (GVP, GCP, ICH guidelines, Pharmaceuticals and Medical Devices Act) Experience in regulatory inspections and audits
• Highly effective written, oral, and interpersonal communication skills in Japanese and Business-level English is required.
• Demonstrated ability to think strategically, lead through change and build teams.

Preferred

• Experience in global/matrix organization
• Project management experience (system implementation or transformation)
• Knowledge of digital/automation tools (e.g., RPA, AI in PV)
• Vendor outsourcing/transition experience
• Knowledge of ICSR management

＜For Internal Applicants＞

• Based on your experience and interview evaluation, the position title and level may vary.
• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.

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