Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.

No, thanks

BOOK A MEETING BOOK A MEETING
   
Sign In
ai-pharmacovigilance-translation

What Is Pharmacovigilance and Why It Matters for Global Drug Safety

Pharmacovigilance is the science and process of monitoring the safety of pharmaceutical products through the detection, assessment, and prevention of adverse effects. It serves as a critical safeguard for public health, ensuring that drug risks are identified and mitigated throughout the product lifecycle.

Accurate, timely translations play a central role in global pharmacovigilance—especially for adverse event (AE) reports, safety narratives, and clinical trial data. As life sciences companies operate across multiple regions, multilingual translation becomes essential to maintain both the clarity and integrity of safety information.

International regulatory authorities such as the FDA (U.S.), EMA (Europe), and PMDA (Japan) require that pharmacovigilance data be submitted in the appropriate regional languages. Failing to meet these language and reporting requirements can delay approvals or trigger compliance risks. By supporting multilingual safety reporting, translation contributes directly to both patient safety and regulatory success.

Read More Read Less

The Role of AI in Pharmacovigilance Translation

Artificial intelligence plays a critical role in optimizing the translation of pharmacovigilance content, including adverse event (AE) reports, patient narratives, and safety data. As global regulatory pressures increase and submission volumes grow, AI enables pharmaceutical and biotech organizations to meet strict timelines without compromising quality or compliance.

Advanced AI models trained on medical and pharmacovigilance-specific corpora can accurately translate complex clinical language, including drug names, symptom descriptions, and regulatory phrases. This level of linguistic precision supports the delivery of safety-critical content across multiple languages.

AI dramatically reduces turnaround times by processing large volumes of AE reports and structured data in parallel. This scalability ensures timely reporting for global pharmacovigilance teams and regulatory authorities, especially during product launches or safety signal escalations.

AI systems integrated with translation memory (TM) and terminology databases automatically apply approved vocabulary across projects. This consistency is vital for ensuring accurate, compliant safety documentation and harmonized reporting across languages and geographies.

Machine-generated translations are reviewed and refined by expert linguists trained in pharmacovigilance and regulatory affairs. This hybrid approach—AI-powered translation followed by human post-editing—delivers high-quality results while maintaining compliance with ISO 17100 and regional regulatory standards.

Sesen’s AI-enabled workflows are designed to reduce risk, enhance linguistic consistency, and improve efficiency in pharmacovigilance translation. By combining automation with subject matter expertise, we support faster decision-making and safer outcomes for patients worldwide.

Key Benefits of AI for Pharmacovigilance Translation

AI-enabled translation workflows offer a strategic advantage for life sciences companies managing high volumes of multilingual safety data. From accelerating timelines to ensuring regulatory precision, AI supports scalable, compliant pharmacovigilance processes across global markets.

AI accelerates the translation of adverse event (AE) reports and safety data, enabling timely submissions to regulatory authorities such as the FDA, EMA, and PMDA. Automated pre-processing and language model inference significantly reduce turnaround times, helping sponsors meet strict pharmacovigilance deadlines.

AI tools incorporate validated terminology databases and rule-based logic to align translated content with regional pharmacovigilance regulations. When combined with human review, these workflows reduce the risk of translation errors that could result in regulatory delays or miscommunication of safety information.

AI systems are capable of supporting simultaneous translation into multiple target languages, ensuring that pharmacovigilance communications remain consistent across markets. This multilingual scalability is critical for sponsors operating in regions with diverse regulatory and linguistic requirements.

AI streamlines the overall translation lifecycle by automating repetitive tasks, enabling human linguists to focus on post-editing and compliance validation. This hybrid model reduces project costs while maintaining the high linguistic and regulatory standards required in drug safety communications.

By integrating AI into pharmacovigilance translation, Sesen empowers pharmaceutical, biotech, and CRO clients to improve operational efficiency, maintain compliance across regions, and reduce costs—all while safeguarding patient health.

AI-Supported Workflows for Adverse Event Reporting

Sesen’s AI-powered translation workflows are built to support the timely, accurate, and compliant delivery of adverse event (AE) reports and safety data across languages. These intelligent processes ensure regulatory readiness, even in high-pressure scenarios such as global product launches or unexpected safety signal escalations.

Each adverse event report enters a structured workflow that begins with AI-generated translation using pharmacovigilance-trained language models. The output is automatically checked for terminology consistency, formatting accuracy, and structural alignment. Human linguists specializing in drug safety and regulatory language then post-edit the translation to ensure clarity, accuracy, and compliance with region-specific regulatory requirements.

Sesen’s AI systems handle a wide range of pharmacovigilance content types, including clinical narratives, laboratory summaries, periodic safety update reports (PSURs), and clinical trial adverse event logs. AI identifies standard patterns and medical terms, ensuring fast and accurate translation while preserving the context necessary for regulatory review and pharmacological analysis.

AI streamlines repetitive elements of the translation process, including template formatting, reference tag handling, and glossary insertion. This automation frees up linguistic experts to focus on validation, interpretation, and compliance tasks, resulting in higher-quality outputs and reduced time to delivery.

Sesen’s AI-enhanced workflows deliver speed, scale, and precision, helping life sciences companies stay ahead of compliance timelines and maintain global pharmacovigilance standards without compromising linguistic quality.

Quality Assurance in AI-Powered Pharmacovigilance Translation

In pharmacovigilance, translation quality is non-negotiable. Errors or inconsistencies in adverse event (AE) reports or safety data can compromise regulatory submissions and patient safety. That’s why Sesen integrates robust quality assurance (QA) practices into every stage of our AI-powered translation workflows.

While AI accelerates initial translation, final output quality is governed by expert linguists trained in pharmacovigilance and regulatory requirements. These professionals review AI-generated content for accuracy, medical appropriateness, and alignment with regulatory context. Their role ensures that translations are both linguistically precise and legally defensible.

Sesen applies a multi-layered QA process that combines automated and human review. AI-powered tools perform checks for terminology consistency, source-target alignment, formatting accuracy, and language fluency. These tools are integrated with translation memory (TM) and pre-approved glossaries to ensure consistent usage of technical terms across all safety documentation.

All pharmacovigilance translations follow internationally recognized quality standards, including ISO 17100 for translation services and ISO 13485 where applicable for medical device safety data. Sesen’s workflows are designed to meet the compliance expectations of major health authorities such as the FDA, EMA, and PMDA. Our QA framework supports audit readiness, document traceability, and full transparency in the translation lifecycle.

By combining advanced AI capabilities with domain-expert oversight and certified quality standards, Sesen delivers high-accuracy pharmacovigilance translations that meet the demands of regulatory authorities and support safe, compliant global drug monitoring.

Trusted Experts in AI-Enhanced Pharmacovigilance Translation

Sesen is a trusted partner for global pharmaceutical, biotech, and clinical research organizations seeking high-quality pharmacovigilance translations powered by AI. With a specialized focus on life sciences, we bring a deep understanding of drug safety workflows, regulatory reporting standards, and multilingual compliance.

Our teams combine domain-specific linguistic expertise with advanced AI technologies to streamline translation workflows for adverse event (AE) reports, safety narratives, and clinical trial data. Sesen’s AI-enhanced solutions are designed to scale with global pharmacovigilance demands while maintaining regulatory-grade quality.

We are committed to meeting the stringent requirements of international health authorities, including the FDA, EMA, PMDA, and Health Canada. All translations follow rigorous quality protocols and are certified under ISO 17100, the global standard for translation services. This certification reflects our dedication to accuracy, transparency, and process integrity.

Sesen’s proven track record includes supporting pharmacovigilance operations for leading pharmaceutical companies and CROs. Our tailored workflows, regulatory expertise, and AI integration capabilities position us as a leading provider in the life sciences translation space—ensuring our clients stay compliant, efficient, and globally connected.

Read More Read Less

Frequently Asked Questions

AI accelerates the translation of adverse event (AE) reports, safety narratives, and clinical trial data by automating the initial translation phase using domain-trained language models. These models are optimized for medical terminology and regulatory language, enabling faster and more accurate content processing. AI also assists in automating QA checks and formatting tasks, reducing turnaround time while maintaining consistency.

Sesen supports the AI-powered translation of a wide range of pharmacovigilance content, including individual case safety reports (ICSRs), periodic safety update reports (PSURs), development safety update reports (DSURs), risk management plans (RMPs), clinical safety narratives, and lab result summaries. Each document type is handled within customized workflows to meet both linguistic and regulatory requirements.

Our workflows integrate AI technologies with ISO 17100-certified translation practices. Every AI-generated translation undergoes human post-editing by linguists experienced in regulatory compliance. In addition, our QA processes incorporate terminology validation, consistency checks, and adherence to regional regulatory authority guidelines such as those from the FDA, EMA, and PMDA.

Human linguists play a critical role in post-editing AI-generated translations. They validate the linguistic accuracy, contextual appropriateness, and regulatory alignment of each document. Their domain expertise ensures that the final output meets both industry standards and the expectations of regulatory bodies, bridging the gap between automation and quality assurance.

Yes. Sesen’s AI-enhanced workflows are built to scale, allowing for the rapid processing of high-volume pharmacovigilance content across multiple languages. This capability is essential for organizations managing global safety reporting obligations or responding to increased reporting demands during clinical trials and post-marketing surveillance.

Quality is ensured through a multi-step process that combines AI-based tools and expert human oversight. Automated QA checks flag issues such as inconsistent terminology, formatting errors, and untranslated segments. These are reviewed and resolved by certified medical linguists, ensuring that every translation meets the quality benchmarks required for regulatory submission and audit readiness.

Success Stories: How AI Transforms Pharmacovigilance Translation

Sesen’s AI-powered translation solutions have helped leading pharmaceutical and biotech organizations streamline their pharmacovigilance workflows, reduce reporting delays, and improve multilingual consistency. Below are real-world examples that demonstrate the impact of combining artificial intelligence with deep life sciences expertise.

  • Challenge: A top-10 pharmaceutical company was struggling to meet tight regulatory deadlines for multilingual adverse event (AE) report submissions during a global drug rollout.
  • Solution: Sesen implemented an AI-driven translation workflow that automated the initial translation of AE narratives and safety data, followed by post-editing by ISO 17100-certified linguists.
  • Outcome: The client achieved a 30% reduction in turnaround time for translated AE reports across six languages, meeting all regional compliance timelines and reducing internal workload.
  • Challenge: A fast-growing biotech company faced inconsistencies in translated safety data across its European and Asian regulatory filings, putting submission timelines at risk.
  • Solution: Sesen deployed AI-supported translation solutions integrated with translation memory and terminology databases tailored to the client’s pharmacovigilance glossary.
  • Outcome: The company enhanced consistency in terminology across all safety documentation, streamlined collaboration across regional teams, and improved audit readiness—positioning itself for faster market expansion.

Each success story underscores how Sesen’s AI-powered translation workflows support faster, more accurate, and fully compliant pharmacovigilance communication—enabling clients to meet regulatory demands and protect patient safety on a global scale.

Ready to Optimize Your Pharmacovigilance Translation?

Ensure faster, compliant, and cost-effective translations for adverse event reports, safety narratives, and regulatory submissions. Sesen combines AI technology with life sciences expertise to support your global pharmacovigilance efforts at scale.

REQUEST A QUOTE REQUEST A QUOTE
SPEAK TO A EXPERT SPEAK TO A EXPERT