99 PV Red Sheet Practice Exam

Literature screening in pharmacovigilance is the systematic process of scanning medical literature to identify new safety signals and to confirm or refute existing signals. It adds value by capturing adverse event information that may not appear in routine reporting, including rare or long-term effects and signals in specific patient groups. By evaluating reports from case reports, case series, observational studies, and systematic reviews, reviewers can corroborate signals found in spontaneous reports and provide context on incidence, severity, and risk factors. This evidence informs regulatory decisions, risk minimization, and labeling updates, and it complements other data sources. It’s distinct from randomized trials in new populations, which are primary research studies, and from supply chain activities like auditing contracts or managing distribution channels, SAMPLEwhich are not about detecting or assessing safety signals.