Sr. Manager, Icsr Quality

CSL Behring

Hybrid
Global case management vendor oversight
Icsr quality strategy development
Pharmacovigilance database knowledge
The role involves overseeing the operational management and activities performed by Global Case Management Pharmacovigilance vendors for multiple CSL entities

Job Summary

  • The role involves overseeing the operational management and activities performed by Global Case Management Pharmacovigilance vendors for multiple CSL entities.
  • Candidates must possess a minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance experience along with global regulatory knowledge.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other areas.

Matching Summary

The role involves overseeing the operational management and activities performed by Global Case Management Pharmacovigilance vendors for multiple CSL entities.

Skills & Requirements

Must-have

  • Global case management vendor oversight
  • ICSR quality strategy development
  • Pharmacovigilance database knowledge
  • Regulatory rules and regulations proficiency
  • Third-party relationship management

Nice-to-have

  • Experience with emerging issue resolution
  • Audit and inspection support capabilities
  • CAPA contribution for case quality
  • Hybrid work schedule flexibility

Key Requirements

  • BS/BA, RN, Pharmacist, or equivalent degree
  • Minimum 8 years PV experience
  • Global pharmacovigilance database knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter