Post-Market Surveillance: Ensuring Ongoing Drug Safety

Post-market surveillance keeps watch on product safety after approval through spontaneous reports, periodic aggregate reports, additional monitoring where required, post-authorization safety studies or other studies, and feedback into labeling and risk minimization. The job is ongoing benefit-risk management with evidence, not a one-time launch checklist. Commitments that exist only in an approval letter and never in an operating calendar are a common failure mode.

Viltis helps marketed-product teams design surveillance plans that match product risk and regulatory commitments. That includes signal and case oversight interfaces, PBRER/PSUR inputs, risk management plan measure tracking, and coordination with medical affairs and quality when field complaints overlap drug safety. We keep commitments visible so promised activities do not quietly expire, and we help define who owns each loop from detection to action. Cross-functional ownership is named so PV is not left holding actions it cannot execute alone.

Periodic benefit-risk reporting only works if case processing, signal outputs, and medical review feed the authors on a calendar that is real. We help build those input pipelines and ownership maps so PBRER or PSUR cycles are not a quarterly scramble. The same discipline applies to additional monitoring lists and educational material commitments tied to the RMP. New indication or new market launches get an explicit surveillance update so obligations scale with exposure. Labeling change triggers are tested against recent signal outcomes.

Post-market surveillance support often includes

• Surveillance plan and commitment tracking
• Aggregate reporting input coordination
• RMP measure implementation checks
• PASS and registry interface planning
• Complaint-AE reconciliation processes
• Labeling update trigger workflows
• Inspection readiness for PMS documentation

Surveillance only works if findings change practice when they should. We help teams keep the loop closed from case and signal to action so post-market safety is managed as an operating system, not a binder on a shelf. When products expand to new markets or indications, we help update the surveillance plan before volume and obligations outgrow the original design. If RMP commitments or periodic reports are slipping, we rebuild the operating calendar and ownership map so surveillance work stays visible between crises.