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Pharmacovigilance and translation part two: Providing a solution to sector challenges

Pharmacovigilance and translation part two: Providing a solution to sector challenges [Photo: iStock/Cecilie_Arcurs]
in Healthcare

Pharmacovigilance is a vital stage of any drug’s introduction. Whether it’s in the testing stage or further down the line, the monitoring of the drug’s performance and any related adverse reactions to it is important in ensuring public safety.

However, one of the challenges is that a side effect or adverse event in relation to a drug could take place anywhere in the world. Whether the event has taken place in France, Germany or Spain, it needs to be reported in the same way, so translation becomes an important factor.

Here, we take a look at a few more challenges related to pharmacovigilance and translation.

Subject matter expertise

As with any other type of medical sector translation services, there can be issues that arise in pharmacovigilance translation when you’re dealing with specialisms and clinical sectors. For example, while both respiratory and oncological issues often fall under the same banner, they require attention from doctors with very different specialist knowledge. It’s the same in the world of pharmacovigilance, and at the translation stage, it’s vital that we understand that.

It’s important that any translation company can provide experts in specific sectors, because if they don’t, there can be some real challenges. For example, we often receive large amounts of documentation. Much of this can be somewhat illegible or hard to understand, particularly for medical records that consist of handwritten notes that are scanned to PDF format and sent over.

In these cases, a linguist who is familiar with the general healthcare translation process but not experienced in managing pharmacovigilance content could really struggle to get it right. Someone with additional therapeutic expertise has the ability to not only translate verbatim, but also to understand and interpret what the original note taker or document creator was trying to get across.

The biggest challenges that arises from not having subject matter expertise comes in the shape of lost time and confidence. When someone does not know complexities that arise within pharmacovigilance, there tends to be a lot of back and forth between the general healthcare linguists and the translations operations team, making enquiries and asking about meanings, as well as creating a general fear and unwillingness to participate due to the implications of mis-translations. However, because of the granularity of how we work in terms of specific therapeutic experience and sector expertise, our translators and adverse event certified project teams are experts in the management of pharmacovigilance related documentation, which fundamentally reduces the time spent on queries.


One of the hardest things to deal with in pharmacovigilance, compared to other documentation translation services, is that you often simply don’t know how many files are going to arrive at any one time. For any given case, there could be ten documents that are sent across one day, followed by five the next day and then 60 on another. This unpredictability makes it cumbersome to put in place a hard and fast process of sourcing translators and making sure there’s always someone available to deal with problems that arise.

Knowing the precise demand is a completely impossible ask. After all, you can just never tell how many adverse events may occur at any stage of the process, or how many files this is going to lead to. For this reason, it’s vital that we look at how we scale for volume fluctuations considering a level of unpredictability.

To do this, we over source from a linguistic capacity. So we retain all linguists to be able to deal with peaks and troughs in demand from clients in the pharmacovigilance sector. An effective translation provider can also be quite intelligent when it comes to dealing with challenges that can emerge, by predicting potential outcomes. For example, during post marketing surveillance for a drug that deals with respiratory issues, there’s a higher chance of people developing issues in winter as opposed to summer, so the translation provider can scale resources to provide services during this period of the year.

Documentation challenges

Another big challenge in pharmacovigilance is documentation differences. Unlike other sectors we deal with, the pharmacovigilance market sees us manage a number of different types of documentation across each project, including:

  • Individual case safety report – where there is a single patient per adverse form report. We can be dealing with a lot of these with varying levels of criticality, at once during any project
  • Aggregate reports –over time, a more detailed overview of the safety profile of a drug is collated, allowing for a broader evaluation of the risk/benefit profile. This changes and adapts as all information and tests are evaluated and added to the data over time. These are bigger documents and version control is essential
  • Articles and publications – medical journals publicise articles about drugs and trials, all of which also need to be translated with up to date insight

Varying file formats are a core operational challenge in the pharmacovigilance translation process. Because documentation in formats such as scanned PDFs are coming in, there are complexities around using software that allows the linguists to take advantage of repetitions to improve consistency, throughput and cost reduction. This technology can only be used with editable files, which scanned PDFs, for example, are not. With 24 hours or less for critical cases to do this, it can be hard to hit targets.

Aside from using highly trained pharmacovigilance operation and project teams, it is also important to look at providing efficiencies within the workflow and process. For example, by introducing standardised adverse event templates, utilising a central portal to track, submit and centrally review changes, and integrating translation workflow with back-end and customer facing platforms. This creates a much faster and efficient process on the whole.

By leveraging our expertise in the translation process and pharmacovigilance workflow, we provide a lean and agile service that recognises each of these challenges, adapts to them individually, and comes together into an end-to-end turnkey solution that works for the client in the most cost efficient way possible.

For more on challenges in the world of pharmacovigilance, check out part one of our series.

