Local Case Intake Team Manager, GBS Patient Safety

Job Title: Local Case Intake Team Manager, GBS Patient Safety Introduction to role Are you equipped to handle a high-performing patient safety intake team that protects patients by ensuring fast, accurate, and compliant adverse event report. In the role of Korea-based Manager coordinating case intake operations locally, you will coordinate case intake for assigned Marketing Companies and/or countries across the region.

You will ensure every Individual Case Safety Report is processed carefully and promptly to meet regulatory requirements and internal standards. ards. You will guide a team of Advisors for local case submissions. You will set clear performance goals. You will develop conditions for excellent execution by translating sophisticated regulations into robust local processes that deliver measurable results.

As a leader, you will connect local operations to the worldwide patient safety strategy. You will maintain the Pharmacovigilance System Master File, ensuring it is current and audit-ready. You will build positive relationships with Health Authorities. Do you thrive at the intersection of science, regulation, and people leadership where your decisions directly influence patient outcomes and business continuity?

Accountabilities Team Leadership and Development: Lead, coach, and mentor the regional case intake group; set performance expectations, deliver training, and build a culture of accountability and improvement. End-to-End Case Intake Oversight: Ensure timely intake, processing, and submission of ICSRs and follow-ups in line with local regulations and AstraZeneca standards; secure continuity of service through robust coverage and after-hours processes.

Regulatory Compliance and Audit Readiness: Maintain up-to-date local procedural documents and SOPs; prepare for and participate in audits and inspections to sustain a consistently audit-ready state. Coordinate interactions and queries from regulators. Act as the point of contact for sophisticated customer concerns. Ensure high-quality, data is submitted on time. Performance and Continuous Improvement: Supervise metrics and service level agreements for the intake function.

Analyze trends, find bottlenecks, and implement measures to ensure accurate and issues to improve speed, quality, and compliance. Process Governance and SOPs: Implement and align local processes with international patient safety criteria; ensure consistency between global and local practices and change communication. Data Quality and PSMF Accuracy: Verify correctness and completeness of case data and ensure local pharmacovigilance information is accurately reflected in the PSMF.

Cross-Functional Collaboration: Build strong partnerships with Medical, Regulatory, Quality, Commercial, and teams; support local safety management agreements and clinical study protocol requirements. Scientific and Literature Surveillance Support: Support assessment of non-serious events and upgrades per the Consistently Critical List; support literature surveillance in accordance with local and global requirements.

Training and Systems Proficiency: Ensure team completion of required patient safety training and effective use of global PS systems (e.g., Argus). Risk Management and CAPA Delivery: Ensure timely and effective corrective and preventive actions for any non-compliance or SLA breaches; prevent recurrence through root-cause analysis. Participate in ad-hoc local, regional, and global case handling projects.

Serve as a liaison local operations and global Patient Safety for process updates and guidelines. Essential Skills/Experience Degree qualified in Pharmacy, Medical, or Science, or with equivalent experience 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