Clinical Research

Pharmacovigilance Translations

Getting authorization to market your product is a huge milestone, but it is by no means the end of the clinical journey. Once your product is out in the world, it is your responsibility – including from a regulatory perspective – to monitor its usage in all markets. Pharmacovigilance is a set of activities to ensure safety, monitor for adverse events, and generally assess the risk/benefit balance of your product.

With over 20 years of experience in life sciences, the Conversis team have helped shepherd countless products into international markets. Through the pharmacovigilance translation services we provide to our clients, we also have the opportunity to make sure those products continue to help their intended users.

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Clinical Research

Our Pharmacovigilance Translation Expertise.

Most major regulatory bodies, like the FDA and EMA, require pharmacovigilance reporting on an ongoing basis for regulatory compliance. But producing this reporting often involves managing a significant volume of data across countries and languages. Content is often in non-editable, scanned, and even handwritten formats. Each country can have different requirements, and use different systems, producing a variety of data types.

Yet – despite the weight and variability of data, and the inevitable noise this creates – it’s absolutely crucial to identify those data points and events that are significant, and to do so extremely quickly. In the case of serious adverse events, especially, moving quickly can save lives.

At Conversis, we combine expert linguists who are on the ground in the relevant countries with AI-assisted workflows to ensure accuracy and nuance within necessarily tight timelines. We make sure our clients are consistently up to date with what is happening with their product in international markets so they can act accordingly and in good time.

Pharmacovigilance Content We Translate

Batch records
Adverse event reports (AERs)
Individual Case Safety Reports (ICSRs)
Periodic safety update reports (PSURs)
Risk management plans (RMPs)
Literature screening

…and more!

The Benefits of Working With Conversis.

Specialists exclusively in life sciences

20+ years of experience

3,000+ linguists

330+ language combinations

People on the ground in 110 countries

All linguists qualified in life sciences

Certified ISO 9001, 17100 & 27001

Work with 18/20 top pharma globally

Track record in 50+ therapeutic areas

Coverage of entire clinical product lifecycle

AI workflows designed for pharmacovigilance

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Trusted by Life Sciences Organizations Globally

What our clients say about working with us.

“I really appreciate you looking for ways to get this project over the line, and for your patience in explaining the processes to me. You guys make translations so much less stressful than my experiences before. Thank you!””

Key Account Manager, Global Pharmaceuticals Company

“Conversis is a great partner to work with. They are extremely responsive and accommodating from start to finish. They provide a high-quality service and enable us to hit deadlines for important clients. We consider them one of our trusted partners, and they have never let us down.”

Project Manager at Langland

“I know some of the requests on these studies have not been typical and we have asked a lot of Conversis, but you really have stepped up and delivered. With your attention to detail, knowledge of the processes, diligence, and hard work to ensure the job gets done, you have made a significant impact on the work we are able to deliver here at IQVIA.”

Shelby Terry, Senior Patient Recruitment Specialist at IQVIA

Case Studies.

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Translation Services in Over 330 Language Combinations:

Our extensive network of linguists spans the globe, with experts residing in their respective countries, covering all regions worldwide. They allow us to offer pharmacovigilance translation services in over 330 language combinations, matching linguists to projects based on their subject area expertise. Each linguist is vetted and their experience verified before onboarding, and they are continually assessed throughout their relationship with Conversis.

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Pharmacovigilance Translations FAQs.

What are the key regulatory requirements for pharmacovigilance translations?

Pharmacovigilance reporting is a requirement for all major global regulatory bodies. The key requirements in terms of translation are that translations are accurate, use consistent terminology, and adhere to specific formats. It is also crucial that reporting (and therefore translation) happens in a timely manner so any issues detected can be addressed swiftly. Conversis works with expert linguists and implements our ISO-backed quality processes to ensure accuracy. We utilize translation memory and termbases to ensure consistency. We implement AI-assisted processes for speed, including OCR (optical character recognition) to tackle tricky formats.

How long do your pharmacovigilance translation services take?

Each new project is assessed by the project team, who produce a quote detailing costs and timelines. By way of a rough estimate, standard turnarounds are 2,000 words per day for translation and 1,000 words per hour for review. But timelines can vary based on factors like language combination, complexity, volumes, and service level (e.g., if AI-assisted workflows are applied). To understand timelines for a specific project type, please get in touch.

How do you ensure your translation services are accurate?

At Conversis, we only work with linguists who are specialists in life sciences. We also follow a minimum one-step review process. This means that, once translation is complete, all content is then reviewed by a second linguist with the same qualifications. Where AI workflows are implemented, this is managed by sector experts and content is reviewed by our linguists.

Following the review process, our internal QA team conducts quality checks to validate accuracy, consistency, and adherence to client specifications. Finally, we also use translation memory and termbases to ensure consistency of language within and across projects.