Local Case Intake Team Manager, GBS Patient Safety
On-siteSeoul, Seoul, South Korea
Job Summary
Coordinate case intake operations for assigned Marketing Companies, ensuring timely processing of Individual Case Safety Reports and follow-ups in line with local regulations and AstraZeneca standards. Lead and mentor the regional case intake group, setting performance goals, delivering training, and building a culture of accountability. Maintain the Pharmacovigilance System Master File, ensuring it remains current and audit-ready while managing interactions with Health Authorities. Supervise metrics and service level agreements, analyze trends to identify bottlenecks, and implement corrective actions for non-compliance or SLA breaches. Implement local processes aligned with international patient safety criteria and support literature surveillance and upgrade assessments. Serve as the liaison between local operations and global Patient Safety for process updates and guidelines.
Required Qualifications
- 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
Desired Qualifications
- 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
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