Pharmacovigilance Translations

Providing organizations with highly-accurate and timely pharmacovigilance translation solutions in 250+ languages

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Home 9 Pharmacovigilance Translations

Pharmacovigilance (also abbreviated PhV or PV) is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs). As the global pharmaceutical market shifts overseas, submitting extremely-accurate translations of common pharmacovigilance documents like adverse event (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical to protecting consumers worldwide. With a large network of subject-matter experts and a global network of 10,000 in-country native linguists, CSOFT offers highly-accurate and timely multilingual translation solutions for a wide variety of pharmacovigilance needs in 250+ languages, from DSURS and discharge reports to CIOMs forms and clinical trial documents.

Pharmacovigilance Report Translation

Pharmacovigilance requires documenting and reporting a wide range of adverse drug reactions (ADRs) such as adverse reactions (ARs), serious adverse reactions (SAR), serious adverse events (SAE), and suspected unexpected serious adverse reaction (SUSAR) to investigators and regulatory bodies. Because pharmacovigilance reports must be thoroughly written and submitted quickly to identify what caused adverse drug reactions in as little time as possible, providing timely and highly-accurate translations of pharmacovigilance reports are essential. With a team of 10,000 in country linguists and subject-matter experts, CSOFT can provide highly accurate translations of DSURs, SUSARS, SAEs, Ars, and AEs to enable effective pharmacovigilance monitoring and reporting.

Learn more about our medical document translations.

 Multilingual Clinical Trials

After drugs have been approved for market, some sponsors will hold Phase IV clinical trials to conduct additional pharmacovigilance on the drug’s safety. However, as more clinical trials are being conducted overseas, having effectively translated and localized patient recruitment material and other multilingual clinical trial documentation is vital for conducting effective pharmacovigilance. CSOFT can help organizations enhance pharmacovigilance by providing high-quality clinical trial documents and patient recruitment translations in 250+ languages.

Learn more about our clinical trial translation services.

Data Security

We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.

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Quality Assurance

High-quality translation is extremely important in pharmacovigilance – inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality translation solutions for pharmacovigilance. In order to do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our localization best practices through linguistic validation, back translation, and terminology management, we have the tools and team to help you meet the submission demands of regulatory bodies such as the FDA, EMA, and NMPA.

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