Forward to: Drug Safety

Pharmacovigilance
Analytics Workflows

Ten agent workflows for Drug Safety — adverse event monitoring, signal detection, REMS compliance, safety labeling changes, post-market surveillance, FAERS analysis, global safety database intelligence, risk-benefit assessment, safety communication tracking, and pharmacovigilance dashboard — enabling proactive drug safety management powered by comprehensive domain intelligence.

1Adverse Event Signal Detection

AI agent monitors FDA adverse event databases, medical literature, and social media platforms to detect emerging safety signals before they become regulatory actions.

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Detect Emerging Safety Signals
/compliance/press/docsOpenPageRank
SAFETY SIGNAL DETECTION — 14 PRODUCTS MONITORED ════════════════════════════════════════════════════════ fda.gov — FAERS Database /compliance: Product A — 342 new AE reports this quarter /docs: Disproportionality analysis: hepatic events PRR 2.8 (elevated) ALERT: Hepatotoxicity signal emerging — convene safety review board who-umc.org — WHO VigiBase /products: Product B — international signal for cardiac events /press: 3 countries issued safety communications SIGNAL: Coordinate global safety response across 28 markets SIGNAL PRIORITIZATION: Critical: 1 (Product A hepatotoxicity) Watch: 3 signals under evaluation Closed: 8 signals assessed — no action required ACTION: Emergency safety review board meeting — 48 hours

2Competitor Safety Intelligence

AI agent monitors competitor product safety profiles, label changes, and regulatory actions to identify competitive advantages and inform risk-benefit positioning.

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Track Competitor Safety Profiles
/compliance/press/productsIAB Categories
COMPETITOR SAFETY LANDSCAPE ════════════════════════════════════════════════════════ fda.gov — Recent Safety Actions: lilly.com — Mounjaro: New thyroid cancer warning added novonordisk.com — Ozempic: Pancreatitis warning strengthened pfizer.com — Paxlovid: Black box warning for drug interactions COMPETITIVE SAFETY POSITIONING: Our Product vs Competitor: Superior hepatic safety profile Our Product vs Competitor B: Similar cardiovascular risk OPPORTUNITY: Market safety advantage vs competitors with new warnings

3REMS Compliance Monitoring

AI agent monitors REMS program requirements, FDA assessments, and compliance metrics to ensure all REMS obligations are met and programs operate effectively.

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Track REMS Compliance
/compliance/docs/productsOpenPageRank
REMS COMPLIANCE DASHBOARD ════════════════════════════════════════════════════════ Product D — Full REMS with ETASU: Prescriber certifications: 4,200 (98% compliance) Patient enrollment forms: 12,400 processed Assessment due: March 15, 2026 — 23 days ACTION: Complete REMS assessment submission on time Product E — Communication Plan: Dear Healthcare Provider letters: Distributed to 45,000 HCPs Medication Guide updates: Current REMS PORTFOLIO STATUS: Products with REMS: 3 | Compliant: 3 Upcoming assessments: 1 (March 15) FDA feedback pending: 1 modification request

4Safety Labeling Intelligence

AI agent monitors FDA and EMA labeling changes across the pharmaceutical industry to track safety-related label updates, new warnings, and contraindication additions.

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Track Labeling Changes
/compliance/docs/pressCountries
SAFETY LABELING CHANGE TRACKER ════════════════════════════════════════════════════════ OUR PRODUCT LABEL CHANGES (2026): Product A: New hepatotoxicity warning — submission pending Product B: No changes required Product C: Updated pregnancy category — Q2 submission COMPETITOR LABEL CHANGES (LAST 90 DAYS): Class-wide GLP-1 warnings: Thyroid cancer, pancreatitis JAK inhibitors: Boxed warning for MACE, malignancy Bispecific antibodies: CRS management guidelines added REGULATORY TREND: Label changes (2025): 847 — record high Safety-related: 62% of all changes SIGNAL: Increased FDA scrutiny on post-market safety monitoring

5Global Safety Communication

AI agent monitors regulatory agencies worldwide for safety communications, Dear Doctor letters, and product recalls to coordinate global safety responses.

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Track Global Safety Communications
/press/compliance/docsCountries
GLOBAL SAFETY COMMUNICATION TRACKER ════════════════════════════════════════════════════════ fda.gov (US): Safety communication on GLP-1 class — Feb 12 ema.europa.eu (EU): PRAC review of Product B — ongoing pmda.go.jp (Japan): No actions pending — clear tga.gov.au (Australia): Updated CMI for Product D — complete COORDINATION STATUS: Countries with aligned labeling: 24 of 28 Labeling discrepancies: 4 countries — harmonization needed ACTION: Harmonize EU/Japan labeling for Product B within 90 days

6Benefit-Risk Assessment

AI agent monitors evolving benefit-risk frameworks, HTA assessments, and regulatory guidance to inform benefit-risk communication strategies for marketed products.

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Track Benefit-Risk Frameworks
/docs/press/aboutOpenPageRank
BENEFIT-RISK ASSESSMENT INTELLIGENCE ════════════════════════════════════════════════════════ fda.gov /docs: Updated Benefit-Risk Framework — patient preference integration /press: Patient-focused drug development guidance finalized OUR PRODUCT BENEFIT-RISK PROFILES: Product A: Benefit-risk shifting — hepatotoxicity signal under review Product B: Favorable — strong efficacy, manageable safety Product C: Highly favorable — best-in-class safety profile COMPETITIVE BENEFIT-RISK: Product C vs Competitor X: Superior safety with equivalent efficacy RECOMMENDATION: Leverage safety advantage in HTA submissions

7Literature Safety Monitoring

AI agent monitors medical literature for safety-relevant publications, case reports, and systematic reviews that could affect product safety profiles.

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Monitor Literature Safety Signals
/blog/press/docsIAB Categories
MEDICAL LITERATURE SAFETY MONITORING ════════════════════════════════════════════════════════ pubmed.ncbi.nlm.nih.gov New publications mentioning our products: 142 (last 30 days) Safety-relevant: 18 Requiring ICSRs: 4 case reports PRIORITY PUBLICATIONS: 1. Product A: Case series — 3 hepatic events in elderly patients ALERT: Consistent with emerging FAERS signal 2. Product B: Meta-analysis — no cardiovascular signal confirmed FAVORABLE: Supports current safety profile 3. Class review: Systematic review of our drug class — balanced FAVORABLE: Our product best-in-class on safety endpoints

8Inspectorate Intelligence

AI agent monitors regulatory inspectorate activities to track GVP inspection trends, common findings, and enforcement actions that inform PV system audit preparation.

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Track PV Inspection Trends
/compliance/press/docsCountries
PV INSPECTORATE INTELLIGENCE ════════════════════════════════════════════════════════ fda.gov /compliance: Top GVP inspection findings (2025): 1. Inadequate signal detection procedures (38% of inspections) 2. Late ICSR submissions (32%) 3. Insufficient medical review of AE reports (28%) OUR INSPECTION READINESS: Last FDA inspection: October 2024 — No critical findings ICSR submission timeliness: 99.2% on time Signal detection process: Needs update per new ICH E2E Next expected inspection: Q3 2026 ACTION: Update signal detection SOPs before Q3 inspection

9Safety Database Technology

AI agent monitors pharmacovigilance technology providers to track AI-powered AE processing, automated signal detection, and next-generation safety database capabilities.

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Track PV Technology Innovation
/products/press/case-studiesOpenPageRank
PV TECHNOLOGY LANDSCAPE ════════════════════════════════════════════════════════ oracle.com — Argus Safety /products: AI-powered ICSR processing — 80% auto-completion /press: Cloud migration — Argus Cloud now available SIGNAL: Evaluate Argus Cloud for our safety database migration iqvia.com — Vigilance Hub /products: NLP-based AE extraction from medical literature /case-studies: 65% reduction in literature review time drughunter.com /products: AI safety signal prediction platform /press: Predicted 3 FDA safety actions 6 months before announcement SIGNAL: Evaluate predictive PV technology for early signal detection

10Pharmacovigilance Dashboard

AI agent synthesizes all safety intelligence into an executive dashboard — providing leadership with real-time visibility into product safety profiles, signal status, and compliance health.

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Generate PV Intelligence Dashboard
/compliance/press/docsOpenPageRankCountries
PHARMACOVIGILANCE DASHBOARD — FEBRUARY 2026 ════════════════════════════════════════════════════════ SAFETY SIGNALS: Critical: 1 (Product A hepatotoxicity) Under evaluation: 3 | Closed: 8 COMPLIANCE: ICSR timeliness: 99.2% | REMS compliance: 98% Labeling harmonization: 24 of 28 countries aligned UPCOMING: REMS assessment: March 15 Expected inspection: Q3 2026
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Generate PV Report

Pharmacovigilance Report — February 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── Products monitored: 14 across 28 markets AE reports processed: 4,200 this quarter Safety signals: 1 critical, 3 under evaluation REMS programs: 3 products compliant KEY INSIGHTS Product A hepatotoxicity signal requires immediate safety review board convening. Competitor GLP-1 class warnings create positioning opportunity for our products. ICSR timeliness at 99.2% exceeds industry benchmark. FDA inspection expected Q3 2026 — signal detection SOPs need update per new ICH E2E guidance.
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