Project Manager

Pharmacovigilance Project Manager

Location

Tokyo (Onsite)

About the Role

Cognizant is seeking an experienced Pharmacovigilance (PV) Project Manager to support one of our global pharmaceutical clients in Japan. This client-facing role will serve as the primary onsite representative for Pharmacovigilance operations, ensuring seamless service delivery, stakeholder management, and operational excellence across the PV engagement.

The successful candidate will act as the bridge between the client and Cognizant delivery teams, driving project execution, issue resolution, process optimization, and continuous improvement initiatives while ensuring compliance with regulatory and quality standards.

Key Responsibilities

Client & Stakeholder Management

• Serve as the primary point of contact for all Pharmacovigilance operational matters.
• Build and maintain strong relationships with client stakeholders.
• Facilitate effective communication between the client and offshore/onshore delivery teams.
• Provide regular project updates, performance reports, and risk assessments to stakeholders.
• Manage client expectations and ensure timely resolution of requests and concerns.

Project & Service Delivery Management

• Oversee day-to-day Pharmacovigilance operations and service delivery.
• Ensure all deliverables are completed within agreed timelines and quality standards.
• Monitor project performance through KPIs, metrics, and governance frameworks.
• Identify operational risks, issues, and bottlenecks, and implement mitigation plans.
• Act as the first escalation point for service delivery and operational concerns.

Pharmacovigilance Oversight

• Provide operational leadership across Pharmacovigilance activities including:
  • ICSR case processing
  • Quality Control and Quality Review
  • Literature surveillance support
  • Aggregate reporting support
  • Metrics and compliance reporting
• Ensure adherence to client procedures, regulatory requirements, and global PV standards.
• Support audits, inspections, and quality initiatives as required.

Team Leadership

• Provide guidance, mentoring, and operational support to Pharmacovigilance team members.
• Drive collaboration across global delivery teams.
• Monitor workload distribution and resource utilization.
• Support performance management and capability development initiatives.

Continuous Improvement

• Identify opportunities to improve processes, quality, productivity, and compliance.
• Lead process improvement projects and best-practice sharing initiatives.
• Support automation and innovation efforts within Pharmacovigilance operations.

Required Qualifications

Education

• Bachelor's degree or higher in:
  • Pharmacy
  • Medicine
  • Nursing
  • Life Sciences
  • Biomedical Sciences
  • Related Healthcare Discipline

Experience

• Minimum 5 years of experience in Pharmacovigilance, Drug Safety, Clinical Research, or related pharmaceutical operations.
• Minimum 3 years of Project Management experience in a pharmaceutical, CRO, or life sciences environment.
• Minimum 2 years of people leadership or team management experience.
• Strong understanding of end-to-end Pharmacovigilance processes and regulatory requirements.
• Experience managing client-facing projects and stakeholders.

Technical & Functional Skills

• Strong knowledge of:
  • ICSR Management
  • Quality Control / Quality Review
  • Drug Safety Operations
  • Pharmacovigilance Metrics & Reporting
  • Risk and Issue Management
• Ability to manage large volumes of operational data and performance metrics.
• Strong analytical and problem-solving capabilities.

Language Requirements

Japanese

• Native Japanese speaker or JLPT N1 equivalent.

English

• Business-level communication skills (spoken and written).
• Ability to lead meetings and communicate with global stakeholders.

Preferred Qualifications

• Experience working in a global outsourcing or managed services environment.
• Experience supporting multinational pharmaceutical companies.
• PMP, PRINCE2, or equivalent Project Management certification.
• Experience leading cross-functional and geographically dispersed teams.

Key Competencies

• Client Relationship Management
• Leadership and Team Development
• Project Management
• Risk Management
• Communication and Stakeholder Engagement
• Continuous Improvement Mindset
• Customer Focus
• Decision Making
• Collaboration and Influencing Skills
• Quality and Compliance Orientation