Senior Quality Manager (m/f/d)

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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 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. 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. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. contract service providers) and relationship management. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world s largest plasma collection networks, CSL Plasma. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. To learn more about inclusion and belonging visit careers/inclusion-and-belonging If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit accessibility-statement .
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Location:
Maidenhead
Job Type:
FullTime

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