Patient safety depends on more than what happens inside a company's walls. Much of the critical work in pharmacovigilance case processing, literature monitoring, signal management, medical information is carried out by external partners. When that network of vendors operates to the highest quality standards, the system works. When it doesn't, the consequences are real.
This role exists to make sure it works.
Why this role matters
PV quality oversight is often invisible when it's done well and very visible when it isn't. As the internal authority on GVP vendor quality, you will be the person others turn to when the questions are difficult. If you take quality seriously, understand the regulatory landscape deeply, and want to shape how a global company manages its external PV network, this is a role with real scope to make a difference.
What you will do
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 a...