OBJECTIVE To investigate th e status quo and hot spots of domestic and foreign pharmacovigilance research ，so as to provide reference for scientific evaluation of drug safety. METHODS Relevant literature were searched from Web of Science and CNKI during the inception to Mar. 31st，2021. Excel 2019 software and CiteSpace 5.7R2 software were used to visualize and analyze the co-occurrence ，clustering and burst of annual document volume ，researchers，countries/regions，institutions and keywords. RESULTS & CONCLUSIONS A total of 5 422 foreign literature and 966 domestic literature were included ，with an increasing trend year by year. The cooperation between foreign researchers was relatively close ，while the cooperation between domestic researchers was less. A close network of cooperation was set up ，mainly in Europe and the United States. China although the late start ，but since 2018，there was a relatively rapid development trend and has continued so far. In domestic literature ，the organizations with a large number of published literature were mainly national medicine regulatory authorities ，research institute ， colleges and universities ，the cooperation of them was relatively weak. ADR ，drug safety and relevant risk factors are the research hotspots of pharmacovigilance abroad ；the frontier mainly focuses on pharmacovigilance research for vaccines ，drugs and therapeutic methods. The current research hotspot in China is ADR ，and special attention is paid to the safety of traditional Chinese medicine. The establishment of pharmacovigilance system of “Drug Marketing Authorization Holders ”is the research frontier. In the process of drug safety evaluation ，attention should be paid not only to the monitoring and reporting of ADR ，but also to the evaluation and application of multi-link and multi-dimensional research evidence of pharmacovigilance ，so as to effectively promote safe and rational drug use.