About this role
Role Overview
- 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