Sr. Manager, Icsr Quality

CSL Behring

Multiple Locations
Hybrid
Global case management pharmacovigilance vendor oversight
Icsr quality strategy contribution
Global icsr reconciliation activities
CSL Behring is seeking a Senior Manager for Individual Case Safety Reports (ICSR) Quality to oversee the operational management and quality of pharmacovigilance activities related to their products. The role requires significant experience in clinical trials, pharmacovigilance, and vendor management, and offers a hybrid work schedule

Job Summary

  • Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to governance, financials, contracts, quality and training, and resourcing.
  • Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
  • Contributes ICSR quality strategy and is responsible for Global ICSR Reconciliation activities.

Matching Summary

Match Score: 85

CSL Behring is seeking a Senior Manager for Individual Case Safety Reports (ICSR) Quality to oversee the operational management and quality of pharmacovigilance activities related to their products. The role requires significant experience in clinical trials, pharmacovigilance, and vendor management, and offers a hybrid work schedule.

Skills & Requirements

Must-have

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

Nice-to-have

  • Relationship management with third parties
  • Develop and update vendor responsibility documents

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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