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
コグニザントについて
コグニザント（NASDAQ: CTSH）は、AI Builderおよびテクノロジーサービスプロバイダーとして、お客様にフルスタックのAIソリューションを構築することで、AI投資と企業価値を結ぶ架け橋となっています。業界、ビジネスプロセス、エンジニアリングに関する当社の深い専門知識を活かし、組織固有のビジネス環境をテクノロジー・システムに組み込みます。これにより、人間の可能性を最大限に引き出し、確かな成果を実現するとともに、急速に変化する世界においてグローバル企業が常に一歩先を行くための支援を行っています。 詳細については、cognizant.ai をご覧ください。
雇用に関する追加情報
本募集に記載されている報酬情報は、掲載日時点で正確なものです。Cognizantは、適用される法令に従い、いつでも本情報を変更する権利を留保します。
応募者は、対面またはビデオ会議による面接への参加を求められる場合があります。また、各面接の際に、現在有効な州政府または政府発行の身分証明書の提示を求められる場合があります。
Cognizantは機会均等雇用主です。応募および選考において、人種、肌の色、性別、宗教、信条、性的指向、性自認、国籍、障がい、遺伝情報、妊娠、退役軍人の地位、その他連邦法・州法・地方自治体の法律により保護されるいかなる特性に基づく差別も行いません。
