Appealing Points:
- Client-facing role serving as the primary onsite representative for Pharmacovigilance operations, driving service delivery, stakeholder management, and operational excellence.
- Opportunity to lead project execution, issue resolution, process optimization, and continuous improvement while ensuring regulatory and quality compliance.
- Work with global pharmaceutical organizations and international teams, contributing to patient safety on a global scale and developing leadership capabilities.
Annual Salary: 12 Million Yen and above
Job Responsibilities:
- Serve as the primary point of contact for Pharmacovigilance operational matters and manage client stakeholder relationships.
- Facilitate communication between client and offshore/onshore delivery teams.
- Provide project updates, performance reports, and risk assessments, and manage client expectations.
- Oversee day-to-day Pharmacovigilance operations and service delivery.
- Monitor project performance through KPIs, metrics, and governance frameworks.
- Identify operational risks, issues, and bottlenecks and implement mitigation plans.
- Provide operational leadership across ICSR case processing, Quality Control/Quality Review, literature surveillance support, aggregate reporting support, and metrics/compliance reporting.
- Ensure adherence to client procedures, regulatory requirements, and global PV standards.
- Support audits, inspections, and quality initiatives.
- Provide guidance, mentoring, and operational support to team members.
- Drive collaboration across global delivery teams and monitor workload distribution and resource utilization.
- Identify and lead opportunities for process, quality, productivity, and compliance improvement.
- Support automation and innovation efforts within Pharmacovigilance operations.
Job Qualifications:
- Bachelor's degree or higher in Pharmacy, Medicine, Nursing, Life Sciences, Biomedical Sciences, or a related Healthcare Discipline.
- 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.
- Strong knowledge of ICSR Management, Quality Control/Quality Review, Drug Safety Operations, Pharmacovigilance Metrics & Reporting, and Risk and Issue Management.
- Ability to manage large volumes of operational data and performance metrics.
- Strong analytical and problem-solving capabilities.
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.
Langauges Required: Native level Japanese (or JLPT N1 equivalent) and Business level English
Company Description:
One of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era.
Their unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses.
Headquartered in the U.S., this company is one of the Fortune 500 companies and is consistently listed among the most admired companies in the world.
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