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
关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
补充雇佣信息
薪酬信息截至本职位发布之日为准。Cognizant 保留在适用法律允许的范围内随时修改该信息的权利。
申请人可能需要通过现场面试或视频会议的方式参加面试。此外，候选人在每次面试时可能需要出示其当前所在州或政府签发的有效身份证件。
Cognizant 是一家提供平等就业机会的雇主。在招聘过程中，您的申请和候选资格不会因种族、肤色、性别、宗教、信仰、性取向、性别认同、国籍、残疾、遗传信息、怀孕、退伍军人身份或任何其他受联邦、州或地方法律保护的特征而受到影响。
