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GVP Vendor Oversight and QA Lead (EU)

Company

CSL

Location

Maidenhead, United Kingdom

Type

Full time

About the role

This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management, medical information and call centre providers. You will lead the end-to-end PV vendor lifecycle: defining qualification and risk-based oversight strategy, owning quality agreements, overseeing CAPAs, and driving issue management and continuous improvement, ensuring adherence to GVP, data integrity and applicable PV regulations. You will be the senior quality point of contact for PV vendor matters, partnering with and influencing relevant stakeholders.

What you will do

  • Define and own the risk-based qualification and requalification strategy for PV vendors, and own the negotiation and maintenance of Quality Agreements.
  • Establish vendor KPIs, SLAs, dashboards and governance forums, and lead periodic reviews to hold vendors accounta...
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