Case Management Intake Manager in London

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'll

oversee 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's

a 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. Based

in

Maidenhead, UK. Hybrid, 3 days a week on site Why It Matters Regulators

don't

forgive 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 or

don'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 For You'll be the standard-bearer for how intake gets done

not performing the work

yourself, but

making sure the vendor who does performs it to the letter of CSL's processes, PV agreements, and global regulatory guidelines.

You'll

build 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 and

maintain

the 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,

representing

the 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)

Significant

experience

in 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 is

advantageous

Clear, confident communication skills, with the judgment to spot problems in case entry and help implement practical fixe

d

Experience with regulatory inspections and internal audits

advantageous

Strong knowledge of AE and drug coding conventions (MedDRA, WHO-DD) and Good Pharmacovigilance/Documentation Practices

TPBN1_UKTJ