Drug safety monitoring doesn't end at approval—it intensifies. Post-market surveillance reveals rare adverse events, drug interactions, and population-specific risks invisible in clinical trials. Regulatory agencies worldwide demand sophisticated pharmacovigilance systems that capture, analyze, and report safety data in real-time. System failures risk patient harm, regulatory action, and product withdrawal.
Pharmacovigilance compliance spans complex requirements—FDA's REMS, EMA's GVP modules, ICH guidelines, and country-specific regulations. Systems must handle spontaneous reports, literature surveillance, clinical trial safety data, and aggregate reporting while maintaining quality, timeliness, and accuracy across global operations.
We audit global and regional PV systems—including case intake, triage, medical review, coding, regulatory reporting, aggregate signal detection, risk management planning, and safety database controls. Interfaces with quality, medical information, and commercial functions are examined for data flow and governance.
Findings drive prioritized remediation plans that strengthen compliance with global safety reporting requirements and improve real-world risk detection—supported by our PV specialists who can backfill, train, or manage workloads during change.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.