This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers including safety and PV CROs
Job Summary
This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers including safety and PV CROs.
The successful candidate will define risk-based qualification strategies, own quality agreements, and lead periodic reviews to hold vendors accountable.
CSL Seqirus is a major contributor to influenza prevention globally with state-of-the-art production facilities in the U.S., U.K., and Australia.
Matching Summary
This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers including safety and PV CROs.
Skills & Requirements
Must-have
3+ years GVP or PV quality experience
Direct pharmacovigilance vendor oversight
Ownership of quality agreements
Knowledge of audit and inspection management
Expert knowledge of GVP Modules and EU legislation
Nice-to-have
Postgraduate qualification in scientific discipline
Strong communication and negotiation skills
Ability to work autonomously
Experience with ALCOA+ data integrity principles
Key Requirements
Bachelor's degree in relevant scientific discipline