Local Case Intake Team Manager, GBS Patient Safety
Core
Lead a local case intake team in Korea to ensure accurate, timely processing and reporting of Individual Case Safety Reports (ICSRs) for patient safety compliance.
Role type
Senior IC Team Manager (Pharmacovigilance)
Builds
Operational rigor in adverse event reporting and regulatory compliance for medicines.
Domain
Healthcare / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
Pharmacovigilance expertise, Regulatory compliance knowledge, Team leadership, Cross-functional partnership, Project management, Data stewardship, Risk management, Quality oversight, Systems management
Preferred skills
Experience managing case intake teams, Hands-on experience with Argus or similar safety databases, Audit and inspection readiness, Quality Management Systems (QMS) knowledge, PSMF maintenance, Organized Data Collection Programmes, Metrics analysis
Technologies
Argus
Responsibilities
Lead and coach a local case intake team; Oversee end-to-end intake, processing, and reporting of ICSRs; Maintain local procedures aligned with global standards; Guide Local Case Intake Advisors during interactions with public health agencies; Monitor benchmarks and SLAs to drive improvements; Conduct quality checks and implement corrective actions; Serve as liaison to Medical, Regulatory, Clinical, and Commercial teams; Communicate local insights to global collaborators; Support delivery of Risk Management Plan commitments; Ensure robust after-hours processes and team coverage; Oversee use of global patient safety systems.
Seniority
Senior, hands-on IC with team leadership
