CSL · 1 day ago
Sr. Manager, ICSR Quality
King of Prussia, PA
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expCSL Behring is a global biotherapeutics leader driven by our promise to save lives. In this role, the Senior Manager, ICSR Quality will oversee the operational management and activities of Global Case Management Pharmacovigilance vendors, ensuring quality and compliance in case processing.
BiotechnologyMedical DeviceHealthcareHealth CareHealth DiagnosticsMedical
Responsibilities
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
Oversee case management vendor(s) to manage and resolve emerging issues
Develop and/or maintain/ update existing documents for relevant vendor responsibilities
Contributes ICSR quality strategy
Responsible for Global ICSR Reconciliation activities
Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required
Qualification
Required
BS/BA, RN, Pharmacist, or equivalent
Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations
Experience working with third parties (e.g., contract service providers) and relationship management
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
Company data provided by crunchbase