WHY GLOBAL PHARMACOVIGILANCE NEEDS AI | CHAPTER 6The Power of AI Solutions


For pharmaceutical companies looking to achieve swift, streamlined pharmacovigilance case management, AI innovation offers an exciting way forward.

With the support of a Language Service Provider (LSP) with experience in pharmacovigilance, AI-powered machine translation (MT) can be coupled with expert human oversight to rapidly translate complex technical documents at scale, returning large volumes of high-quality material to meet regulatory requirements.

AI translations remain under the watchful eye of human experts so pharmaceutical companies can be confident that translations are accurate.

AI can also optimize many parts of the case processing workflow, reducing the need for human intervention and thereby freeing up personnel and resources for other tasks.

By automating as much of the workflow as possible but retaining expert human oversight throughout, pharmaceutical companies can see significant efficiency and productivity gains and increase their ability to manage the ever-increasing amount of pharmacovigilance information needing timely analysis.

Combining AI solutions with expert oversight is a delicate balance.

To ensure accuracy, quality, and compliance in your pharmacovigilance case processing, it’s crucial to partner with an LSP that has proven expertise and experience managing multilingual content using AI.

The Many Benefits of Using AI

AI enables pharmacovigilance case management that is:

  • Faster: A good AI-powered LSP can deliver tens of thousands of words of pharmacovigilance translations each day via MT, and ensure a TAT of 24h or less across all content and languages — no matter the volume.
  • More cost-effective: Traditional models for outsourcing case processing can be costly, with both minimal and rush fees typically applied. These fees drive up translation costs and result in a high cost-per-word charge. AI solutions can handle large volumes of translations on demand and make minimum, desktop publishing, and rush fees obsolete, providing total translation costs that are up to 5x lower than traditional translation approaches.
  • Efficient: AI improves efficiency by automating time-intensive routine tasks (such as triage, booking, data entry, template-building, and file conversion) so companies can focus their time and talent on higher-value activities. Importantly, AI can return accurate, high-quality technical content across languages via MT and can quickly identify possible language patterns and potential AEs within large volumes of information, further expediting pharmacovigilance operations.
  • Accurate: MT engines can be trained on medical glossaries and relevant regulatory material to be client-specific for specialized pharmacovigilance content and equipped to identify acronyms across languages. While a hugely powerful and valuable tool, AI should not be left unchecked to produce unverified information; a good LSP will ensure continual and expert human oversight to ensure accuracy.

The ‘efficiency versus expertise’ dilemma

Traditionally, AI-powered MT engines have fallen short of the quality of human translation. However, humans alone cannot meet the rising demand for rapid translations in multiple languages at scale. Combining AI with human expertise produces a solution that avoids this problem and offers the best of both worlds, returning translations of equivalent quality to a ISO 17100 certified translation.

Further Reading: Navigating ISO Certificates: A Guide to Selecting an LSP

  • Consistent: Large global organizations traditionally procure language services through local offices and siloed LSPs, leading to diverse pricing, processes, timelines, outcomes, and quality. AI-powered LSPs offer a better way forward and provide the capacity for global support, increasing cohesion and consistency across regions.
  • Scalable: Unlike solely human teams, AI-powered engines can handle very large volumes of reports for translation, and can readily be scaled up or down as needed across regions and languages. Additionally, a good LSP will not require customers to commit to a case minimum of ICSR translations per day or per language, instead offering a ‘pay per word’ approach for optimal flexibility and scalability.
  • Secure: When considering the world of AI, many companies worry about how sensitive data is managed. However, AI translation via a reputable LSP ensures that data is kept secure, private, and treated according to relevant standards.