Pharmacovigilance

Pharmacovigilance at Viltis covers drug safety work across development and post-market: adverse event reporting, ICSR management, signal detection, literature surveillance, audit readiness, QPPV-related support, and observational / real-world safety studies. The focus is processes and case quality that meet clocks and inspection questions.

Sponsors and partners usually need help when case volume outruns the team, partner handoffs miss expedited windows, signal or aggregate reporting is thin, or an audit is approaching. We help design and run PV operations without pretending volume alone equals a working safety system.

Use the capabilities below to open a specific service page, or contact us if you want a gap review of your current PV setup. Viltis provides consulting and resourcing; we do not issue QPPV licenses or act as a regulatory authority.

Pharmacovigilance capabilities in this practice area include

• Adverse Event Reporting Across Clinical Trials and Post-Market
• Comprehensive ICSR Management for Global Compliance
• Proactive Signal Detection and Risk Management in Drug Safety
• Pharmacovigilance Gap Analysis
• Post-Market Surveillance and Literature Surveillance
• Pharmacovigilance Audit Preparation and Internal Audits
• QPPV Oversight and European PV Standards Support
• Observational Studies and Real-World Evidence in Drug Safety