Case Management Intake Manager

CSL; Maidenhead; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

On-site in Maidenhead

Job summary

CSL in Maidenhead (UK) is seeking an Intake Lead for Adverse Events to oversee the vendor responsible for logging and triaging every case. You will ensure correct capture, timely processing, and adherence to global regulatory guidelines, influencing downstream pharmacovigilance activities.

The role is hybrid—3 days on site in Maidenhead—with a strong focus on process governance, training, and audit readiness. A life sciences degree and PV experience are essential to succeed.

Qualifications

• Degree in life sciences or equivalent professional background.
• Significant pharmacovigilance experience, with direct case management preferred.
• Working knowledge of global pharmacovigilance databases and regulatory requirements.

Responsibilities

• Oversee the Global Adverse Events Inbox and vendor case entry into CSL's global safety database.
• Provide training and ongoing support to the vendor on triage-related processes.
• Create and maintain guidance documents for intake and book-in.
• Oversee E2B file imports and coordinate with IT to resolve issues.
• Act as SME for intake and triage in cross-functional projects and SOPs.
• Own audit and inspection readiness for case intake, including CAPA management.

Skills

Communication skills

Case management platforms

Pharmacovigilance experience

Regulatory inspections knowledge

MedDRA/WHO-DD knowledge

Documentation practices (GxP)

Education

Degree in life sciences

Job description

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 fixed
• Experience with regulatory inspections and internal audits advantageous
• Strong knowledge of AE and drug coding conventions (MedDRA, WHO-DD) and Good Pharmacovigilance/Documentation Practices