Human Pharmacovigilance Services

End-to-end Pharmacovigilance Support. Built on Trust.

End-to-End PV Support, Powered by Automation

We support safety teams from clinical development to post-market, combining deep pharmacovigilance expertise with technology-enabled solutions. Here’s how we help:

Our Human PV Services Include

Regulatory Oversight & Scientific Governance

For organisations that need experienced PV leadership or external QPPV support.

Virtual PV & QPPV services
Pharmacovigilance system setup and management
Regulatory representation and governance

Signal & Surveillance Services

To help you detect, assess, and act on safety signals — faster and more confidently.

Signal detection & benefit-risk evaluation
Literature monitoring (global + local)
ICSR and case surveillance (medicines, devices, cosmetics)
Aggregate reporting (PSURs, PBRERs, DSURs)
Risk management plan (RMP) support

Compliance, Quality & Operational Excellence

For building audit-ready PV systems that scale.

SOPs, audit readiness, and inspection support
Training for PV teams
System validation and process optimisation
Ongoing QA, compliance monitoring, and continuous improvement

Built on the Biologit Platform

Literature monitoring is delivered via our GxP-validated, audit-ready platform — the same technology trusted by top pharma and CROs in 170+ countries.

So you’re not just getting advice — you’re getting a system that works.

Is your current system doing enough?

Biologit delivers efficiency, compliance, and control — all in one place