Sr. Manager, ICSR Quality

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The Opportunity: Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality , you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products. This is a hybrid role, which offers a combination of an onsite and remote work schedule . #LI-hybrid The Role: 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 manage...
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Location:
Maidenhead
Salary:
not provided
Job Type:
FullTime
Category:
Engineering

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