CSL Ltd is seeking a Senior Manager for ICSR Quality, responsible for overseeing the operational management of Global Case Management Pharmacovigilance vendors. The role includes ensuring compliance and quality in the processing of Individual Case Safety Reports (ICSRs) and offers a hybrid work schedule
Job Summary
The Senior Manager, ICSR Quality will be responsible for the oversight and control of the operational management and activities performed by Global Case Management Pharmacovigilance vendor(s).
Key responsibilities include ensuring consistency and monitoring quality and compliance of end-to-end case processing and other outsourced activities.
This is a hybrid role, offering a combination of an onsite and remote work schedule.
Matching Summary
Match Score: 85
CSL Ltd is seeking a Senior Manager for ICSR Quality, responsible for overseeing the operational management of Global Case Management Pharmacovigilance vendors. The role includes ensuring compliance and quality in the processing of Individual Case Safety Reports (ICSRs) and offers a hybrid work schedule.
Skills & Requirements
Must-have
Oversight of Global Case Management Vendors
Monitor quality and compliance
Global ICSR Reconciliation activities
Vendor governance and financials
Nice-to-have
Contributes ICSR quality strategy
Support audit/inspections
Develop and update documents
Key Requirements
BS/BA, RN, Pharmacist, or equivalent
Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance experience
Global pharmacovigilance database knowledge
Proficient knowledge of global and local regulatory rules
Experience working with third parties and relationship management