Medical literature is an important source of information on suspected adverse reaction case reports. As regulations are becoming more stringent, Marketing Authorization Holders (MAHs) may face the challenge of incorporating ever-increasing safety data into their Pharmacovigilance (PV) practices to achieve compliance. The quality and efficiency of the literature monitoring in the pharmacovigilance process have a significant impact on the quality of ICSRs, periodic safety reports, detection of new safety signals, and eventually Benefit-Risk Evaluation (BRE) of medicinal products. Importantly, shortcomings in the critical process of literature monitoring and literature screening pharmacovigilance processes have the potential to impact the MAH’s overall Pharmacovigilance activities. These activities include Regulatory compliance and have a potential impact on the company’s reputation due to inadequate Benefit-Risk Evaluation (BRE) of the products leading to potential drug recalls.

As a part of the literature screening pharmacovigilance process, PharmZi assists organizations with specialized literature monitoring in pharmacovigilance services. PharmZi team ensures the safety is monitored right from Medical Literature Monitoring (MLM), Global literature, and local literature review in identifying ICSRs to signals and information for inclusion in Periodic Safety Update Reports (PSURs).