Local Case Intake Team Manager, GBS Patient Safety

Job description

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 strategically to obtain desired outcomes while maintaining effective, positive interpersonal relationships Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience Shown experience leading or supervising a pharmacovigilance group responsible for case intake in a fast-paced, regulated environment Direct experience with Health Authority interactions and regulatory query management in Korea and/or multi-country settings Hands-on experience with global safety databases and tools (e.g., Argus) and related case processing workflows Proven success in audit/inspection readiness, including SOP implementation and PSMF maintenance Strong benchmark and metrics reporting and operational improvement track record Experience supporting literature surveillance and applying upgrade rules (e.g., Always Serious List) Bilingual proficiency in Korean and English, with the ability to communicate complex regulatory topics clearly to diverse collaborators Why AstraZeneca Join a global organization where patient impact is real and immediate, and where operations perfection powers scientific progress. You will be part of a collaborative network that brings unexpected teams into the same room to address sophisticated problems quickly, using data and digital tools to drive better, faster decisions. Here, you will have the trust and accountability to run with ideas, challenge how things are done, and shape how we deliver safe, compliant outcomes at scale. We value patience alongside ambition and back your growth with learning, feedback, and opportunities across our global community—so your leadership today turns into broader impact tomorrow. Call to Action If you’re ready to lead a group dedicated to safeguarding patients and improving performance across a global enterprise, step forward. Show us how you’ll improve the quality and compliance of case intake.e. Date Posted 23-Jul-2026 Closing 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.