Global PV Intake Manager - Hybrid

CSL Vifor; Maidenhead; Hybrid; GBP 52,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Job summary

CSL Vifor in Maidenhead, UK, seeks a role to oversee the intake of adverse event reports, ensuring the vendor logs and triages accurately, on time, and in line with global regulatory requirements, serving as the quality gate for downstream pharmacovigilance.

The role focuses on building guidance, training the vendor, and owning audit readiness, CAPA management, and cross-functional documentation. Strong experience in PV, case management, and MedDRA/WHO-DA coding is essential.

Qualifications

• Degree or equivalent in life sciences with PV exposure.
• Significant pharmacovigilance or case management experience.
• Knowledge of global PV regs, local and international.

Responsibilities

• Oversee the Global Adverse Events Inbox and vendor entry into the safety database.
• Provide training and ongoing support to the vendor on triage processes.
• Create and maintain intake/guidance documents (SOPs, GDLs, WIs).
• Oversee E2B imports and work with IT to resolve issues.
• Act as SME for intake/triage in cross-functional projects and documentation.
• Own audit/inspection readiness, CAPA management.

Skills

Pharmacovigilance

Case management

Regulatory knowledge

Training & coaching

Audit readiness

Education

Bachelor's degree in life sciences

Tools

Argus

PV databases

Job description

CSL Vifor in Maidenhead, UK, seeks a role to oversee the intake of adverse event reports, ensuring the vendor logs and triages accurately, on time, and in line with global regulatory requirements, serving as the quality gate for downstream pharmacovigilance.

The role focuses on building guidance, training the vendor, and owning audit readiness, CAPA management, and cross-functional documentation. Strong experience in PV, case management, and MedDRA/WHO-DA coding is essential.