Overseeing ICSR Quality and vendor management for Global Case Management at CSL Behring. Ensuring compliance, resolving issues, and supporting audits related to case quality.
Responsibilities
Oversight of Global Case Management Pharmacovigilance vendor(s)
Ensure consistency and monitor quality and compliance of end-to-end case processing
Oversee case management vendor(s) to manage and resolve emerging issues
Develop and/or maintain/update existing documents for relevant vendor responsibilities
Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management.
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 (e.g., contract service providers) and relationship management.
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