Automation and Artificial Intelligence (AI) in Pharmacovigilance

Hello Guys,

Nowadays, Automation and Artificial Intelligence (AI) in Pharmacovigilance is a “Buzz” word in Pharmacovigilance industry.

Automation empowers organizations to recognize greater efficiency, quality of work and the speed at which manual tasks can be accomplished while re-directing valuable resources to focus on higher-order tasks. 

Automation helps in addressing the global requirements of detection, assessment and understanding of drug-related problems including signal detection, risk management, adverse event reporting etc.

Automation and Artificial Intelligence (AI) in Pharmacovigilance
Automation and Artificial Intelligence (AI) in Pharmacovigilance

Why Pharmacovigilance (PV) Automation is need of an hour?

  • Rapid increase in volume of adverse event (AE) cases
  • Strict and complex Global regulations
  • Cost minimization
  • Data science and automation evolving for signal detection and case management
  • More focus on risk/benefit analysis and signal management
  • Need for advanced safety data analytics tools
  • Focus on patient centricity

What are different Automation Platforms in Pharmacovigilance?

It includes

  • Artificial Intelligence (AI)
  • Machine Learning (ML)
  • Robotic Process Automation (RPA)
  • Natural Language Processing (NLP)
  • Big Data Analytics

How Automation helps in Pharmacovigilance process?

  1. Reducing ICSR Case Processing Time
  2. Improved Employee Productivity
  3. Reducing Literature Screening Time
  4. Enhanced Signal Management Processing
  5. Cost Savings
  6. Improvements in Drug’s Risk-Benefit Profile

Traditional PV process vs. Automation PV process

Traditional PV process involves following steps:
  1. Receive and reconcile Adverse Events 
  2. Case triage and checking case validity  
  3. Duplicate check and data entry in PV database  
  4. Quality check
  5. Validate & review uploaded AE data 
  6. Report generation
Automation PV process involves following steps:

  1. Case owner open the case
  2. Automated retrieval of cases, prioritization, validating details and updating status 
  3. Perform duplicate check & uploading data in PV database and data entry
  4. Case now open for QC & reports
If you would like to know more details about Automation in Pharmacovigilance, I am providing links for recorded sessions.

I hope you got some clarity on Automation and Artificial Intelligence (AI) in Pharmacovigilance. Please comment and share with your colleagues.

PV Drug Safety Academy

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