Sr. Manager, Icsr Quality

CSL Behring

Multiple Locations
Hybrid
Icsr quality oversight
Global case management vendor management
Pharmacovigilance vendor governance
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)

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

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).

Skills & Requirements

Must-have

  • ICSR quality oversight
  • Global Case Management vendor management
  • Pharmacovigilance vendor governance
  • Global ICSR Reconciliation
  • Regulatory rules and regulations knowledge

Nice-to-have

  • Inclusion and Belonging culture
  • Patient-focused innovation
  • Cross-functional collaboration

Key Requirements

  • BS/BA, RN, Pharmacist, or equivalent
  • Minimum of 8 years PV experience
  • Global pharmacovigilance database knowledge
  • Experience working with third parties
  • Relationship management experience

Work Rights

Not specified

Tailored Resume

Cover Letter