Local Case Intake Service Manager
Core
Overseeing local case intake service in China, ensuring efficient and compliant handling of adverse event reports and Individual Case Safety Reports (ICSRs) for patient safety.
Role type
Senior IC pharmacovigilance service manager (China)
Builds
Patient safety reporting processes and vendor service delivery
Domain
Pharmaceutical industry + Pharmacovigilance
Required skills
Pharmacovigilance regulations, team leadership, vendor management, regulatory authority liaison, quality assurance, KPI monitoring, contract lifecycle management, medical literature review
Preferred skills
Strategic influence, cross-functional collaboration, project initiative management
Technologies
Argus, PSMF
Responsibilities
Lead and manage local case intake team and service vendors; oversee ICSR intake, processing, and reporting; monitor and analyze intake metrics; ensure compliance with local and global PV regulations; conduct quality checks on completed cases; serve as liaison between local and global levels; manage vendor contracts and performance; support regulatory authority interactions and queries; ensure timely submission of safety documents; mentor newly appointed Case Intake Advisors; manage after-hours reporting processes; coordinate purchase orders and invoice processing for vendors.
Seniority
Senior, hands-on IC with team leadership