Case Management Intake Manager

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.Youlloversee the vendor responsible for logging and triaging every report that lands in CSLs Global Adverse Events Inbox making sure each one is captured accurately on time and in line with global regulatory requirements.Itsa 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 Matters
Regulatorsdontforgive a missed or mishandled adverse event report and neither should the systems built to catch them. This role sits at the point where CSLs global safety obligations either hold ordont. Getting intake right consistently across every source and every market is what keeps CSLs regulatory standing intact and more fundamentally what keeps the signal-detection process that protects patients working as it should.

What Youll Be Responsible For
Youll 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 CSLs processes PV agreements and global regulatory guidelines.Youllbuild 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 vendors case entry into CSLs 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 triagerepresentingthe 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