Literature Surveillance for Pharmacovigilance: Tracking Emerging Risks

Literature surveillance finds ICSRs, special situation reports, and emerging safety information in published and other bibliographic sources that may not arrive through spontaneous reporting channels. Regulators expect a defined process: search strategy, frequency, screening, case creation when required, and escalation of new safety information into signal management. Without documentation of what was screened and why items were included or excluded, the process is hard to defend in audit.

Viltis helps set up and run literature processes that are proportional to portfolio size and risk. We define databases and search strings, screening roles, MedDRA and case criteria for literature-derived ICSRs, and documentation that shows the review trail. Global products often need language and regional source coverage without poorly duplicating every affiliate's effort. Search strategies are revisited after label changes, new indications, or emerging terms of interest so the process keeps pace with the product.

Duplicate management between literature and spontaneous cases needs explicit rules. The same publication can generate multiple ICSRs or none, depending on how abstracts and full text are handled. We help define those rules and the documentation expected when a literature hit becomes a case, a signal input, or a justified exclusion. Local-language sources and conference abstracts are included where product risk and geography justify the extra coverage. Screeners are trained on product-specific terms of interest. Exclusion reasons are retained for sampled audit trails.

Literature surveillance work commonly includes

• Search strategy and source definition
• Screening SOPs and decision logs
• Literature-derived ICSR creation rules
• Escalation paths into signal management
• Vendor literature service oversight
• Metrics for backlog and missed hits
• Inspection-ready literature files

Literature work fails quietly when screens are rubber stamps or searches never update after a label change. Viltis keeps the process specific enough to catch real cases and new risks, and lean enough that teams can sustain it week after week. When a vendor runs screening, we help define acceptance checks so sponsorship of the process remains visible and real. If literature screening is outsourced and poorly evidenced, we tighten search criteria, decision logs, and vendor QC so the process can survive audit sampling.