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Expert AE Report Translations for Global Pharmacovigilance Compliance

Adverse Event (AE) reports are critical safety documents submitted throughout the clinical trial and post-marketing phases to regulatory agencies such as the FDA, EMA, and other global health authorities. These reports document any untoward medical occurrences in study participants and serve as essential components of ongoing pharmacovigilance activities.

In multilingual trials and global drug surveillance programs, translating AE reports with precision and speed is crucial. Inaccuracies or delays can result in compliance risks, regulatory penalties, or delayed market access. AE report translation requires not only linguistic fluency but also a strong understanding of medical terminology, regulatory frameworks, and standardized vocabularies such as MedDRA.

Sesen provides specialized AE report translation services tailored to the needs of pharmaceutical companies, clinical research organizations (CROs), and pharmacovigilance teams. Our life sciences linguists are trained in regulatory terminology and safety reporting formats, delivering translations that meet the stringent quality standards required for global health authority submissions.

By partnering with Sesen, clients gain access to regulatory-grade translations, fast turnaround options, and full lifecycle support for adverse event documentation across more than 150 languages.

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Regulatory Timelines and AE Reporting Obligations

Accurate and timely reporting of Adverse Events is a regulatory requirement in all phases of clinical research and post-marketing safety surveillance. Global health authorities enforce strict pharmacovigilance standards, and translated AE reports must align with jurisdiction-specific submission formats and timelines.

Adverse Event reporting is governed by internationally recognized frameworks, including:

  • FDA regulations under 21 CFR Part 312.32 for Investigational New Drug (IND) applications
  • EMA guidelines outlined in Good Pharmacovigilance Practices (GVP) Module VI
  • ICH E2A standards for clinical safety data management and expedited reporting

These frameworks mandate precise documentation and, when applicable, high-quality translations for regulatory review in multilingual environments.

Timelines vary by event type and regulatory body, but common expedited reporting obligations include:

  • 7-day reporting for unexpected fatal or life-threatening adverse events
  • 15-day reporting for serious and unexpected adverse events that are not immediately life-threatening

These deadlines require rapid translation workflows to ensure compliance and uninterrupted drug development or post-marketing activities.

Translated AE reports are essential for international submissions through platforms such as:

  • EudraVigilance, the EMA’s centralized safety database
  • MedWatch, the FDA’s safety information and reporting program
  • Other national pharmacovigilance systems in Latin America, Asia-Pacific, and the Middle East

Sesen supports these requirements with rapid, high-quality AE report translations designed for regulatory acceptance across global markets.

Precision and Consistency in Adverse Event Terminology

Adverse Event reports are not simple narratives. They contain complex medical terminology, structured data fields, and standardized coding systems that demand precise linguistic accuracy. Regulatory authorities rely on these reports to evaluate drug safety and identify potential risks, making translation quality a critical component of pharmacovigilance compliance.

AE reports often reference MedDRA (Medical Dictionary for Regulatory Activities) codes, clinical trial protocols, and detailed medical histories. Inaccurate translation of these elements can distort the meaning of critical safety data and compromise the integrity of the report. Translators must understand both the terminology and the context in which it is used.

Even minor errors in AE report translation can result in regulatory non-compliance, delayed approvals, or misclassification of adverse signals. Misinterpretation of severity, causality, or outcome terms may lead to flawed pharmacovigilance assessments and impact public health decisions.

Regulatory reviewers expect clear, unambiguous information regardless of the report’s source language. Translations must maintain consistency in style, structure, and terminology to facilitate smooth cross-border review. This is especially critical in multinational trials where multiple regulators may assess the same safety data.

Sesen assigns medically trained, native-speaking linguists who specialize in pharmacovigilance documentation. Our translators are well-versed in AE reporting structures and regulatory expectations. We apply consistent terminology management practices, use validated glossaries, and follow established translation QA protocols to deliver submission-ready results.

A Proven Translation Workflow for AE Reports

Sesen’s AE report translation workflow is designed to meet the high standards of global pharmacovigilance while ensuring regulatory accuracy, consistency, and fast turnaround. Our end-to-end process supports compliance with FDA, EMA, ICH, and other international health authorities by combining linguistic precision with operational efficiency.

Every AE translation project is assigned to native-speaking medical translators with proven experience in pharmacovigilance. Our linguists are trained in interpreting safety data, using MedDRA terminology, and following AE reporting structures across various regulatory jurisdictions.

Each report undergoes a two-step process: initial translation by a subject matter expert, followed by an independent review for accuracy, clarity, and consistency. This layered approach minimizes risk and enhances quality.

We ensure consistent terminology by integrating MedDRA and client-approved glossaries directly into the translation environment. This enables uniform use of technical terms and supports alignment with regulatory standards for adverse event classification and coding.

Sesen preserves the original structure of AE reports, including CIOMS forms, MedWatch forms (3500A), and E2B XML output. Our team delivers translated files that are submission-ready and maintain compatibility with pharmacovigilance databases and safety systems.

Every AE translation undergoes final validation through ISO 17100 and ISO 9001 certified QA protocols. We apply structured checklists, automated quality tools, and expert human review to ensure linguistic and regulatory compliance.

We understand that AE reports often follow expedited submission timelines. Sesen offers 24-hour and same-day delivery options to meet 7-day and 15-day regulatory deadlines without compromising translation quality.

We Translate All AE Report Formats

Sesen supports the full spectrum of Adverse Event (AE) report formats required in global pharmacovigilance. Whether documents are submitted in standardized templates, structured data files, or unformatted text, we deliver accurate translations that align with international regulatory expectations.

Our linguists and production teams are experienced with the most widely used reporting formats, ensuring seamless integration into your safety systems and submission workflows.

Common AE Report Types We Translate

Structured reports detailing adverse events associated with clinical trials or post-marketing drug use.

Council for International Organizations of Medical Sciences forms used for expedited reporting, especially in international trials.

AE reporting format for regulated products in the United States, including drugs, biologics, and medical devices.

XML-based submissions compliant with ICH E2B(R3) standards for global electronic transmission of safety data.

Free-text descriptions that provide clinical context around adverse events, often required in conjunction with structured data.

Tabular AE data used in aggregate safety reports and Periodic Safety Update Reports (PSURs).

Unstructured communication containing initial AE notifications, often requiring cleaning and formatting during translation.

All translated reports maintain the structure and clarity required for pharmacovigilance platforms, including EudraVigilance, the FDA Adverse Event Reporting System (FAERS), and client-specific safety databases.

150 Languages with In-Country Regulatory Expertise

Sesen delivers AE report translations in over 150 languages, supported by native-speaking linguists with in-depth knowledge of regional pharmacovigilance requirements. Our global linguistic network ensures that each translation meets not only linguistic accuracy but also local regulatory expectations for safety reporting.

Our in-country experts understand the formatting, terminology, and submission nuances required by health authorities in every major market. This localized expertise reduces the risk of delays, rejections, or miscommunication during the regulatory review process.

Our Language and Regional Capabilities Include:

German, French, Spanish, Italian, Dutch, Polish, and other EU languages required for European Medicines Agency reporting and EudraVigilance compliance.

Chinese, Japanese, Korean, Thai, and Vietnamese for adverse event reporting to national regulatory authorities in East and Southeast Asia, including the National Medical Products Administration and the Pharmaceuticals and Medical Devices Agency.

Brazilian Portuguese and Latin American Spanish for pharmacovigilance submissions to health authorities such as ANVISA (Brazil), INVIMA (Colombia), and COFEPRIS (Mexico).

Arabic, Turkish, Hebrew, Swahili, and French (for Francophone Africa) to support submissions to regional ministries of health and drug safety authorities across the MENA and Sub-Saharan Africa regions.

Each translation is tailored to the target market’s regulatory standards and linguistic norms, helping life sciences clients ensure compliance and accelerate drug approval timelines in multilingual jurisdictions.

Use Cases for AE Report Translation Services

Accurate translation of Adverse Event reports plays a vital role in ensuring drug safety and regulatory compliance throughout the product lifecycle. From early-phase trials to global post-marketing surveillance, Sesen supports a wide range of use cases where timely, high-quality AE report translations are essential for pharmacovigilance.

Sponsors and CROs conducting trials across multiple countries must submit AE reports to local health authorities in each region’s official language. Sesen enables compliant, multi-language reporting to ensure safety signals are communicated clearly and without delay.

As companies prepare for product registration and market entry in new regions, translated AE documentation becomes critical for meeting pharmacovigilance readiness requirements. We support pre-launch regulatory filings with accurate translations of legacy and ongoing safety data.

Outsourced PV teams rely on efficient workflows and consistent language services to handle growing volumes of AE cases. Sesen integrates seamlessly into outsourced models by offering dedicated linguists, flexible delivery timelines, and secure data handling.

PSURs and other aggregate safety reports often include line listings and AE narratives that must be translated for submission in target markets. Our scalable solutions ensure consistency across individual case reports and summary data.

Pharmaceutical companies are required to monitor safety events even after approval. Sesen provides fast, compliant translations of spontaneous reports, medical inquiries, and other safety communications collected during post-market surveillance activities.

These use cases reflect the broad application of AE report translation services in supporting compliant, safe, and efficient drug development and lifecycle management across global markets.

Trusted by Leading Life Sciences Companies

Sesen is the preferred translation partner for pharmaceutical companies, biotechnology firms, CROs, and regulatory consultancies that require accuracy, speed, and compliance in pharmacovigilance documentation. Our proven expertise in Adverse Event report translation ensures that your safety data is submission-ready for regulators worldwide.

Our linguists are not just fluent in language, they are experts in pharmacovigilance and regulatory communication. Each project is managed by professionals with deep knowledge of AE reporting standards, including MedDRA usage, ICH guidelines, and health authority submission protocols.

Sesen uses a secure translation management system built for life sciences. Our platform supports encrypted file handling, role-based access, and full audit trails. It is fully compliant with HIPAA, GDPR, and other global data protection regulations to safeguard sensitive safety information.

We offer scalable pricing models tailored to the needs of sponsors and CROs managing large volumes of AE cases. Our volume-based discounts and bundled service options make it easier to control costs without sacrificing quality or compliance.

Sesen supports integration with pharmacovigilance and safety databases, including Argus, ArisGlobal, and custom-built systems. Translated reports are delivered in compatible formats and can be imported directly into your workflows, minimizing manual handling and reducing turnaround time.

With Sesen, you gain a strategic translation partner equipped to support global drug safety operations with precision, efficiency, and regulatory confidence.

Related Pharmacovigilance Translation Services

Sesen provides a full suite of pharmacovigilance translation services to support global drug safety compliance. In addition to Adverse Event (AE) report translation, we deliver accurate, regulatory-grade translations for a wide range of safety documents required across clinical and post-marketing phases.

Our services ensure consistency across all pharmacovigilance materials, helping sponsors and CROs maintain compliance with EMA, FDA, ICH, and other health authority guidelines.

Serious Adverse Event (SAE) Report Translation

High-priority translations of life-threatening or unexpected SAEs, with expedited turnaround and strict regulatory alignment.

Narrative Report Translation

Accurate translation of AE case narratives that capture clinical context, patient history, and event chronology for regulatory review.

Periodic Safety Update Report (PSUR) Translation

Translation of aggregate safety data, line listings, and summary reports to support ongoing benefit-risk assessments for marketed products.

Pharmacovigilance System Master File (PSMF) Translation

Translations of the PSMF to document the organization’s global pharmacovigilance system in compliance with EU and international regulations.

These services can be bundled as part of a comprehensive pharmacovigilance language solution to streamline your global safety reporting process.

Ensure Your AE Translations Are Submission-Ready

Ensure your global submissions are accurate, compliant, and delivered on time with Sesen’s expert regulatory translation services.

Whether you’re preparing an IND, MAA, IFU, or multilingual labeling, our team is ready to support your next milestone.

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