Intake & Case Mgmt Lead - PV & Compliance (Hybrid UK)

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

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.