Case Management Intake Manager

Biopharma Careers; Maidenhead; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

CSL Seqirus based in Maidenhead, UK, is seeking a dedicated professional to govern the intake of adverse event reports. You will ensure vendor performance aligns with CSL PV processes, provide training, and lead cross-functional documentation and CAPA readiness.

The role requires strong pharmacovigilance expertise, knowledge of MedDRA/WHO-DD, and experience with regulatory inspections. Hybrid work profile: 3 days on site in Maidenhead.

Qualifications

• A degree or equivalent professional background in a life sciences discipline.
• 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 fixes.
• Experience with regulatory inspections and internal audits advantageous.
• Strong knowledge of AE and drug coding conventions (MedDRA, WHO-DD) and Good Pharmacovigilance/Documentation Practices.

Responsibilities

• 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.
• 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

Skills

Communication skills

Attention to detail

Problem solving

Education

Life sciences degree

Tools

Case manager platforms

Argus

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

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

Watch our 'On the Front Line' video to learn more about CSL Seqirus