PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
Why AI Governance Is Becoming a Differentiator in PV Careers
FDA’s 2026 Good AI Practice principles emphasize context of use, multidisciplinary expertise, data governance, lifecycle management, and clear essential...
Beyond FAERS: How FDA’s AEMS Is Expanding Digital Safety Surveillance
The FDA’s Adverse Event Monitoring System (AEMS) is easy to describe as a modernization of public safety-data access, but that understates what the agency is...
Why Real-Time Safety Visibility Is Becoming a Regulatory Strategy
FDA says AEMS is its new Adverse Event Monitoring System, and the agency also maintains a dedicated page for new safety information or potential signals of...
What the GLP-1 Label Change Says About How Safety Evidence Can De-Escalate
FDA says its comprehensive review of available data did not identify an increased risk of suicidal ideation or behavior with GLP-1 RA medications and...
What the New AEMS Signal Page Means for Safety Intelligence Teams
FDA says that when a potential signal of a serious risk is identified from AEMS data, it will be posted in the required quarterly report in the quarter in...
Why AEMS Signals a More Connected Future for Digital Pharmacovigilance
FDA says its new Adverse Event Monitoring System, or AEMS, is designed as a centralized platform not just for adverse event reports, but also for consumer...
How FDA’s Good AI Practice Principles Translate to Real PV Workflows
FDA’s January 2026 “Guiding Principles of Good AI Practice in Drug Development” lays out ten expectations for regulated AI, including human-centric design, a...
Why EudraVigilance and E2B(R3) Skills Still Matter in 2026
It is easy to assume that modern pharmacovigilance careers are moving entirely toward AI, automation, and advanced analytics. But EMA’s 2026 EudraVigilance...
Why AI Governance Is Becoming a Career Advantage in Pharmacovigilance
There is growing excitement around AI in pharmacovigilance, but one career lesson is becoming clearer: in regulated environments, tool familiarity is not...
Why EudraVigilance Training Is a Compliance Control, Not Just Admin
EMA’s EudraVigilance ecosystem is often discussed in technical terms — electronic reporting, ICSR formats, EVWEB access, registration — but there is an...