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About the Role

The Associate Director, PV Systems and Vendor Management at Johnson & Johnson Innovative Medicine is responsible for leading the strategy, governance, and operational excellence of pharmacovigilance (PV) systems and vendor management. This role ensures PV systems and outsourced activities are compliant, efficient, and inspection and audit ready, aligning with global standards and Japanese regulatory requirements. The role also manages outsourcing budgets and resources, strategic outsourcing planning, and issue resolution between vendors and Local Medical Safety Japan.

Responsibilities

Lead governance and lifecycle management of PV systems in alignment with Global Medical Safety.
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 new tool implementation.
Drive data integrity and inspection readiness.
Lead technical aspects of safety data migration or data transfer for MAH transfer projects.
Manage vendors supporting pharmacovigilance operation activities.
Lead selection, onboarding, and oversight of PV vendors.
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.
Develop and optimize workflows to improve PV efficiency and quality using technology (e.g., AI and other tools).
Ensure timely and compliant ICSR reporting to health authorities.
Support regulatory inspections and internal audits.
Lead CAPA implementation related to systems or vendor quality issues.
Lead and develop a team of system and vendor management professionals.
Develop talents in the group through mentoring, coaching, training, and evaluation.
Assist direct reports in exhibiting performance and provide growth opportunities.
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).

Requirements

Bachelor, Master or other equivalent advanced degree in a biological or medically related field is required.
Minimum 8–10 years of experience in Pharmacovigilance.
Minimum of 5 years of direct team management.
Strong experience in PV systems (e.g., Argus, ArisG, LMSV) and vendor management.
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.
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.

Skills

Developing Others
Global Market
Inclusive Leadership
Leadership
Medicines and Device Development and Regulation
Operations Management
Performance Measurement
Pharmacovigilance
Quality Control (QC)
Quality Management Systems (QMS)
Regulatory Affairs Management
Report Writing
Safety Investigations
Safety-Oriented
Safety Reporting
Serious Adverse Event Reporting
Team Management

Location

Chiyoda, Tokyo, Japan

Work Type

Full-time

Experience Level

Associate Director
8-10 years of experience in Pharmacovigilance
5 years of direct team management

Education Level

Bachelor's Degree
Master's Degree
Other equivalent advanced degree in a biological or medically related field

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Equal Opportunity

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.