Services
Signal Detection & Disproportionality Analysis
Systematic identification and evaluation of safety signals using FAERS and large claims databases, with interpretive reporting contextualized for regulatory decision-making.
Aggregate Safety Reporting
Support for Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and related aggregate safety documents.
Real-World Evidence Study Design
End-to-end design and execution of post-market pharmacoepidemiological studies, including new-user active comparator and propensity score weighted analyses.
AI-Assisted Pharmacovigilance
Application of informatics and machine learning methods to automate and enhance safety surveillance workflows.
About Us
Kairos PV provides post-market pharmacovigilance consulting to small and mid-size pharmaceutical and biotech companies that have approved products but lack dedicated internal safety teams. Our services span signal detection and disproportionality analysis, aggregate safety reporting, real-world evidence study design, and AI-assisted surveillance, delivered by a pharmacoepidemiologist with deep informatics training. Most safety consultants bring one or the other; we bridge both, translating complex multi-database analyses into regulatory-ready outputs your team can actually act on.
Founder
Erin Roberts-McCarthy, MPH is a pharmacoepidemiologist and doctoral candidate in Health Informatics at Rutgers University, where her research focuses on neurology pharmacoepidemiology and post-market drug safety surveillance. She founded Kairos PV to bring rigorous, informatics-driven pharmacovigilance expertise to organizations that need it most.
With over a decade of experience in real-world evidence and pharmacoepidemiology, Erin has worked across the pharmaceutical industry with clients including Moderna, GSK, and AbbVie. Her technical foundation spans FAERS, large claims databases, and the All of Us Research Program, with expertise in disproportionality analysis, new-user active comparator design, and propensity score methods.
Erin also serves as Adjunct Professor at the Rutgers School of Health Professions, where she teaches Clinical Trial Data Management and Pharmacoinformatics.
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