Types of Pharmacovigilance Softwares In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace. Pharmacovigilance software database offers alerts for fast cases, follow-up cases, and reports submission to fulfill regulatory timeline compliance. Any pharmacovigilance safety database must be deposited up to date with the most advanced regulatory requirements and certified to meet international standards and business requirements.Safety databases expedite the reporting of individual and aggregate safety data to authorities and third parties and provide critical information for detecting safety signals and the ongoing evaluation of the risk-benefit profile of the company’s products. Factors to consider include: ● ● ● ●
Costs of maintenance and Implementation Hosting models accessibility Previous experience Interoperability and Compatibility
Let’s know the features of the softwares. Name of the Software
Oracle Argus Safety
Distinctive Features ●
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Oracle Argus Safety is a vast platform invented to address the complex pharmacovigilance requirements of the life science industry. Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions, and integrates safety and risk management functions. Origination of cases via case entry screens Tracking of local data items Support for e-signatures Duplicate search capabilities Local labeling decisions made against local datasheet or license Case views provided to appropriate local affiliate Pictures of core documents and global protocols such as action items on a worklist. Central staging area for evaluating submitted affiliate cases Electronic submission abilities Reporting and Querying cases taken and submitted Audit Trails