MidFull TimeEN
Job Title: Japan Local Case Intake Team 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?
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
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 written and verbal communication skills
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 audits and inspections, with a track record of maintaining inspection readiness
Direct experience managing Health Authority interactions and sophisticated safety queries
Experience contributing to and maintaining the Pharmacovigilance System’s Master File documentation
Benchmark reporting, data quality review, and ongoing improvement methodologies
Literature surveillance for adverse events and familiarity with materials linked to Risk Management Plans
Experience handling after-hours AE intake processes and ensuring operational continuity
Collaboration with Medical Affairs, Regulatory Affairs, Commercial, Quality, and external partners
Join a global community where patient impact guides every decision and where your expertise helps the whole enterprise move faster and smarter. You will work alongside curious, ambitious colleagues who bring together data, technology, and rigorous execution—often uniting unexpected teams in the same room to ignite bold thinking that turns into real-world improvements. We balance high standards with genuine support, valuing understanding alongside ambition, and empower you to own ideas, make quick decisions, and see the benefit of your work in the lives of patients and the momentum of our businesscases to Action:
Lead the team that turns safety data into significant action—bring your pharmacovigilance leadership to AstraZeneca and shape safer, faster outcomes for patients today!
Date Posted
15-May-2026Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
