Position Overview
PV Systems & Process Lead
Patient safety depends on pharmacovigilance systems that work — and work well. In this role, you’ll be at the centre of keeping CSL’s global PV system compliant, continuously improving, and inspection‑ready across Global Clinical Safety & Pharmacovigilance, Global Regulatory Affairs, Global Medical Affairs, affiliates, and commercial operations.
What You’ll Do
- Provide expert GVP and PV legislation guidance across the organization, ensuring regulatory changes translate into timely, concrete action.
- Lead investigation and resolution of deviations and non‑compliances, including root‑cause analysis, CAPA development, and effectiveness tracking.
- Review procedural documents across GCSP, GRA, and GMA for GVP compliance.
- Serve as the primary inspection coordinator for health authority and third‑party PV audits in your region — from readiness planning through to CAPA close‑out.
- Track ...