PV Operations Contractor

Pharmacovigilance Operations Consultant

Walker Cole International is currently partnered with a global biopharmaceutical company who are searching for an experienced Pharmacovigilance Operations Consultant with hands-on expertise using Veeva Vault Safety to manage and collate Phase IV safety data, and capacity to conduct minor configuration alterations to the system itself. The ideal Pharmacovigilance Operations Consultant candidate will:

• Own end-to-end Individual Case Safety Reports (ICSRs) management for a clinical-stage biotech's Phase IV/post-marketing safety program, covering case intake, triage, data entry, follow-up, MedDRA coding and case processing within Veeva Vault Safety.
• Have hands-on Veeva Vault Safety expertise required — this role needs someone entering, processing and reviewing safety data directly in Vault Safety, not just extracting or reporting from it, so you should be ready to detail your exact level of involvement.
• Support minor Veeva Vault Safety configuration: adjusting workflows and case routing, configuring fields, case screens, picklists, user roles/permissions, and notification rules, plus troubleshooting simple system issues without a full IT/Veeva implementation team.
• Ensure regulatory reporting timelines are met through case quality checks, narrative preparation, safety database reconciliation, and support for expedited reporting and submissions, working closely with PV, Clinical, Medical, Regulatory and Quality teams.
• Bring pharmacovigilance operations experience from a biotech/pharmaceutical environment, ideally with rare disease and/or cell & gene therapy exposure, contributing to a compliant, inspection-ready PV function.

ICSR Management / Case Intake / Case Triage / MedDRA Coding / Vault Safety / Data Entry