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.

1. 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 Distinctive Features
Oracle Argus
Safety
● 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

2. While we have discussed many Softwares in Pharmacovigilance, Oracle Argus Safety is a
preferred method for managing drug safety data management. Thus the knowledge of
Oracle Argus Safety is quite advantageous to stay connected in the industry today.
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ARISg ● ARISg is also one of the most employed software in
Pharmacovigilance used by pharmaceutical firms..
● It is used to manage crucial drug safety data worldwide.
● It provides all the functionality needed to manage
adverse reaction requirements and adverse event
reporting of several regulatory authorizations
worldwide.
● It allows for all pharmacovigilance methods from case
entry to automatic generation of resignation ready
adverse event (AE) reports etc.,
● ARISg forms a core element of an integrated
pharmacovigilance and risk management system,
allowing organizations to identify safety risks and
monitor their products.
● ARISg helps advance the management of Adverse
Drug reactions using its advanced automation and
configurable workflow features.
AB Cube:
SafetyEasy
● AB Cube Safety Easy is a compliant-ready multi
vigilance database.
● Its fully united platform of tools and functionality offers
comprehensive and versatile safety data management
via a straightforward, intuitive, and user-friendly
interface.
● SafetyEasy comes with an inbuilt query and reporting
functionality.
● It provides validated outputs designed for expedited
and signal detection, case management, periodic
reports.
● The system is presented as a cloud-based
software-as-a-service (SaaS) solution, regularly
updated to meet current regulatory standards and
industry specifications.
● Defining features for AB Cube SafetyEasy are it's easy
to use integrated functionality, user interface, and ease
of data movement both into and out of the database.