Using Artificial Intelligence in Pharmacovigilance

October 12, 2021

Using Artificial Intelligence in Pharmacovigilance

As we briefly discussed in the previous chapter, Artificial Intelligence (AI) is used to simulate the processes of a human brain with the help of computer systems. It encompasses various technologies, including rule-following, reasoning – using rules to reach rough or specific conclusions, learning, and self-correction.

Implementation areas of AI

In the area of pharmacovigilance electronic systems, AI technologies could be implemented in case collection, consolidated reporting, and signal and quality management.

For example, using machine learning algorithms to automate medical coding according to MedDRA dictionary for medical terms or WHODrug dictionary for medical products.

The image below demonstrates how AI based on a neural network is used to detect and manage signals, find duplicates, and auto-code in the Flex Databases Pharmacovigilance system.

Additionally, AI is used in safety signal detection, including:

  • multimodal signal detection,
  • signal detection using neural networks,
  • predictive signal detection.

In general, AI and other automation technologies in pharmacovigilance allow to eliminate human errors, standardize processes, shorten the processing cycle, and reduce manual work.

Examples of AI technologies 

TechnologyShort descriptionUse cases of pharmacovigilance electronic system 
Machine learning (ML)Machine learning (ML) is a subset of AI, allowing the creation of algorithms that can learn and make predictions based on the data. Instead of following a predefined set of rules and instructions, these algorithms are taught to identify patterns in big data and improve over time and with more data. This technology helps identify potential signals.Case collection, periodic reporting, signal management, and risk management.
Neural networkSystem replicating a neural structure of a mammal’s brain. Neural networks usually consist of multiple layers which are formed by numerous nodes. This technology helps identify potential signals.Case collection, periodic reporting, signal management, and risk management.
Semantic searchSemantic search is meant to improve search accuracy and deliver relevant results by understanding user intentions and search query context.Case collection, periodic reporting, signal management, and risk management.

AI use cases

Use case 1Automated case collection and evaluation of serious adverse events (SAE) from online comments on Indian websites. 

Traditional safety data collection is challenging in this area, however, using of artificial neural networks and sentiment analysis allows to automatically identify characterizations of the researched objects in the emotionally coloured text.

Use case 2. Predicting the safety profile of a developed drug

Researchers combined in vitro data with safety information from FAERS database, and created machine learning models, allowing to predict future adverse events based on the data point from other databases, such as PubMed.

Blog

February 11, 2026
Flex Databases team is looking for a Helpdesk Specialist to join one of our Helpdesk team. 

We are driven by our high mission to make an impact on the Life Sciences industry.  We provide a flexible e-Clinical software system for Clinical Research Organizations (CROs) and pharmaceutical companies.  As a Helpdesk Specialist at Flex Databases, you are going to be at the forefront to support our clients’ clinical operations teams, which means daily work for the benefit of people […]

January 21, 2026
Introducing Risk Management in QMS: a modern, structured way to prevent issues before they happen

In clinical research, “quality” is not only about fixing deviations after the fact. It’s about predicting what can go wrong, acting early, and proving control because risks can affect subject safety, data integrity, and the overall conduct of a study. That is exactly why Risk Management exists: it turns uncertainty into a disciplined, repeatable process […]

December 11, 2025
Flex Databases Wins Three Awards at the Clinical Trials Arena Excellence Awards 2025

Flex Databases has been officially recognized as a triple-category winner in the Clinical Trials Arena Excellence Awards 2025, receiving top honors in Innovation, Product Launches, and Business Expansion. This achievement highlights our growing impact on the global clinical research landscape and reinforces our position as one of the most advanced eClinical platforms in the industry. […]

November 27, 2025
New Microsoft 365 Collaboration in Flex Databases TMF

Flex Databases Solves One of the Biggest Document Management Headaches Clinical teams have long struggled with one persistent problem: managing TMF documents across multiple systems, versions, and stakeholders. Switching between platforms, downloading files, losing track of versions, and waiting for colleagues to finish editing slows down operations and increases compliance risks. With this update, Flex […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.