Assistant Manager- Japanese Language Local Case Intake Manager

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About the role

Job Title: Assistant Manager- Japanese Language Local Case Intake Manager Career Level- D Introduction to role: Are you ready to lead a high-performing pharmacovigilance team that safeguards patients by getting every case right, first time? In this role, you will oversee the process of receiving cases in designated markets. You will ensure adverse event information is handled swiftly, accurately, and compliantly. This supports faster delivery of our medicines to patients. This position may be based in India, working with local Marketing Companies and global partners to maintain steady perfection. You will set the direction for ICSR intake and reporting, steward interactions with Health Authorities, and turn real-time metrics into practical improvements that raise quality and reduce risk. Do you thrive in a fast-paced, digitally enabled environment where your judgement and leadership shape outcomes across multiple markets and functions? Accountabilities: Leadership and Team Performance: Lead, coach, and develop a team of Local Case Intake Advisors to deliver consistent, high-quality case intake and processing. ICSR Oversight and Timeliness: Ensure timely and accurate intake, processing, follow-up, and submission of Individual Case Safety Reports in line with regulations and company standards. Regulatory Compliance Stewardship: Maintain detailed knowledge of local pharmacovigilance regulations, align local practices with global standards, and keep SOPs current and audit-ready. Health Authority Engagement: Coordinate and guide responses to Health Authority queries, acting as a point of contact for sophisticated customer concerns to protect compliance and credibility. Quality and Inspection Readiness: Conduct quality checks, address findings, and drive corrective and preventive actions to close gaps and prevent recurrence. Benchmark Monitoring and Continuous Improvement: Track and analyze operational metrics, produce clear reports, and use insights to improve efficiency, quality, and cycle times. Cross-Functional Teamwork: Build positive relationships with the medical department, regulatory teams, commercial operations, quality assurance, and other collaborators to deliver on safety and business needs. PSMF and Product Knowledge: Ensure accurate, up-to-date contributions to the Pharmacovigilance System Master File and maintain awareness of local product status and reference information. SOP Governance and Training: Implement and maintain local procedures; ensure the team completes required training and is proficient in global systems and processes. Business Continuity and Coverage: Plan coverage and after-hours processes so adverse events can be reported and addressed without interruption. Data and Documentation Management: Oversee compliant filing, archiving, and data quality to support transparency and reliable decision-making. Project and Change Delivery: Contribute to global, regional, and local case-handling initiatives that streamline ways of working and scale guidelines. Crucial Skills/Experience: Degree Qualified – Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and handle priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Experience leading and mentoring local case intake teams in a fast-paced environment Hands-on experience with global patient safety systems (e.g., Argus) Proven support for

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