Every adverse event report that reaches CSL — from a treating physician, a license partner, a regulatory authority — starts its life in one place: intake. This role owns the quality of that starting point.You’lloversee the vendor responsible for logging and triaging every report that lands in CSL’s Global Adverse Events Inbox, making sure each one is captured accurately, on time, and in line with global regulatory requirements.It’sa role built on the principle that everything downstream in pharmacovigilance — every safety signal, every regulatory submission — is only as reliable as the intake that fed it.
BasedinMaidenhead, UK. Hybrid, 3 days a week on site
Why It MattersRegulatorsdon’tforgive a missed or mishandled adverse event report, and neither should the systems built to catch them. This role sits at the point where CSL’s global safety obligations either hold ordon’t. Getting intake right — consistently, across every source and every market — is what keeps CSL’s regulatory standing intact and, more fundamentally, what keeps the signal-detection process that protects patients working as it should.
What You’ll Be Responsible ForYou’ll be the standard-bearer for how intake gets done — not performing the workyourself, butmaking sure the vendor who does performs it to the letter of CSL’s processes, PV agreements, and global regulatory guidelines.You’llbuild the guidance that governs their work, train them against it, and be the person accountable when regulators or auditors come asking how the process holds up.
- Oversee the Global Adverse Events Inbox and all other intake sources, and the vendor’s case entry into CSL’s global safety database
- Provide training and ongoing support to the vendor on triage-related processes
- Create andmaintainthe guidance documents that govern intake and book-in
- Oversee E2B file imports and work with the I&T team to resolve process issues efficiently
- Act as subject matter expert for intake and triage,representingthe function in cross-functional projects and procedural documentation (SOPs, GDLs, WIs)
- Own audit and inspection readiness for case intake, including corrective and preventive action (CAPA) management
Experience Required
A degree or equivalent professional background in a life sciences discipline (Registered Nurse, BS/BA, Physician Assistant, Pharmacist, or medical documentarian)
Significantexperiencein pharmacovigilance or an equivalent setting, ideally with direct case management background
Working knowledge of global pharmacovigilance databases and regulatory requirements, local and international
Experience with case manager platforms is essential, while specific Argus experience isadvantageous
Clear, confident communication skills, with the judgment to spot problems in case entry and help implement practical fixed
Experience with regulatory inspections and internal auditsadvantageous
Strong knowledge of AE and drug coding conventions (MedDRA, WHO-DD) and Good Pharmacovigilance/Documentation Practices
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