【AstraZeneca】【GBS-PS】Local Case Intake Team Manager,Global Business Services
Core
Oversee local case intake for Japan regulatory reporting, ensuring efficient and compliant handling of adverse event reports (ICSRs) and patient safety data.
Role type
Senior IC Team Manager (Pharmacovigilance)
Builds
Local case intake processes and regulatory reporting for Japan
Domain
Pharmaceutical industry + Pharmacovigilance
Required skills
Pharmacovigilance regulations, Team leadership, Japanese (N2+), English (B1+), ICSR processing, Health Authority liaison, SOP management, Audit readiness, KPI analysis, Cross-functional collaboration
Preferred skills
MBA or PhD, Medical/Pharmacy degree, Higher degree in relevant field
Technologies
Argus, Management Information Systems
Responsibilities
Lead and manage local case intake team; Oversee intake, processing, and reporting of ICSRs; Ensure timely submission to local health authorities; Monitor and analyze intake metrics; Participate in audits and inspections; Conduct quality checks on completed cases; Serve as escalation point for Health Authority interactions; Maintain local SOPs and PSMF; Mentor staff and ensure training compliance.
Seniority
Senior, hands-on IC with team management