Senior Manager, ICSR Quality managing Individual Case Safety Reports. Overseeing global pharmacovigilance vendor activities for CSL Behring and related products.
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.
Requirements
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.
Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
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