Sr. Manager, Icsr Quality

CSL Limited

Multiple Locations
Hybrid
Global case management pharmacovigilance vendor oversight
Icsr quality strategy
Global icsr reconciliation activities
CSL Limited is seeking a Senior Manager for Individual Case Safety Reports (ICSR) Quality, responsible for overseeing the operational management of global pharmacovigilance vendors. The role requires extensive experience in clinical trials and pharmacovigilance, focusing on quality compliance and vendor management

Job Summary

  • You will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s).
  • Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

Match Score: 85

CSL Limited is seeking a Senior Manager for Individual Case Safety Reports (ICSR) Quality, responsible for overseeing the operational management of global pharmacovigilance vendors. The role requires extensive experience in clinical trials and pharmacovigilance, focusing on quality compliance and vendor management.

Skills & Requirements

Must-have

  • Global Case Management Pharmacovigilance vendor oversight
  • ICSR quality strategy
  • Global ICSR Reconciliation activities

Nice-to-have

  • Strong relationship management skills
  • Contribute to CAPAs

Key Requirements

  • BS/BA, RN, Pharmacist, or equivalent
  • Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience
  • Global pharmacovigilance database knowledge
  • Proficient knowledge of global and local regulatory rules and regulations
  • Experience working with third parties

Work Rights

Not specified

Tailored Resume

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