Pharmacovigilance Translation: Essential for Global Drug Safety
Pharmacovigilance (PV) involves detecting, assessing, and preventing adverse effects of pharmaceutical products. Regulatory agencies worldwide require precise, timely reporting of drug safety data, making high-quality translations critical for compliance, risk management, and patient safety.
Sesen provides pharmacovigilance translation solutions for life sciences, delivering linguistically accurate, regulatory-compliant documentation in 150+ languages. Our expertise spans adverse event reports, risk management plans, and safety data exchange agreements, supporting pharmaceutical and biotech companies in meeting global regulatory requirements with precision and efficiency.
Why Pharmacovigilance Translation?
Accurate pharmacovigilance translations are critical for global drug safety, regulatory compliance, and risk mitigation. Regulatory agencies—including the FDA, EMA, PMDA, and NMPA—require precise reporting of adverse events, risk management data, and safety communications across multiple languages. Mistranslations can lead to delayed approvals, compliance violations, and patient safety risks, exposing pharmaceutical and biotech companies to legal and financial consequences.
Sesen provides specialized pharmacovigilance translations designed for regulatory scrutiny. Our linguistic precision, regulatory expertise, and technology-driven workflows support life sciences companies in meeting global compliance standards while maintaining data integrity and operational efficiency.
Our Pharmacovigilance Translation Expertise
Sesen specializes in high-precision pharmacovigilance translations, helping life sciences companies navigate complex regulatory requirements worldwide. With extensive experience in drug safety, regulatory compliance, and multilingual risk management, we provide expertly translated adverse event reports, risk management plans, and other critical pharmacovigilance documentation.
Why Leading Life Sciences Companies Trust Sesen:
Subject Matter Expertise
Native-speaking linguists with pharmaceutical, regulatory, and medical backgrounds ensure accuracy in drug safety reporting.
Regulatory Compliance
Translations aligned with FDA, EMA, PMDA, NMPA, and ICH guidelines for seamless global submissions.
Technology-Driven Workflows
Hybrid Translation (HT), translation memory, and secure AI-assisted post-editing enhance efficiency without compromising quality.
ISO-Certified Quality
Fully compliant with ISO 17100, ISO 9001:2015, and ISO 13485:2016, ensuring high standards in life sciences translations.
Our dedicated linguists, regulatory specialists, and advanced technology enable fast, accurate, and secure pharmacovigilance translations that support compliance and global market access.
Pharmacovigilance Documents We Translate
Pharmacovigilance documentation requires precise, regulatory-compliant translations to meet global drug safety standards. Sesen provides specialized translations for a wide range of PV documents, maintaining linguistic and technical accuracy, as well as consistency across all regulatory submissions and safety communications.
Adverse Event Reports (AERs) and Individual Case Safety Reports (ICSRs)
Accurate translations for adverse event reports to support global pharmacovigilance and regulatory compliance.
Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
Multilingual translations of safety assessments to facilitate international drug monitoring and risk evaluation.
Risk Management Plans (RMPs)
Expert translations of risk mitigation strategies to align with international regulatory expectations.
Clinical Study Reports (CSRs)
Regulatory-compliant translations of clinical trial findings for drug approval and post-market safety reviews.
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Precision translations for urgent reporting of unexpected drug reactions to regulatory agencies.
Pharmaceutical Labeling and Safety Information
Linguistically accurate translations of product inserts, package leaflets, and prescribing information for global markets.
Safety Data Exchange Agreements (SDEAs)
Clear, consistent translations of contractual agreements for pharmacovigilance data sharing.
Regulatory Correspondence and Inspection Readiness Materials
Comprehensive translations to support interactions with regulatory agencies and inspection processes.
Regulatory Compliance and Global Standards
Pharmacovigilance translations must meet strict regulatory requirements to support drug safety and market authorization worldwide. Regulatory agencies—including the FDA, EMA, PMDA, NMPA, and Health Canada—mandate precise, multilingual documentation for adverse event reporting, safety updates, and risk management plans. Non-compliance can lead to delayed approvals, regulatory scrutiny, and financial penalties.
Sesen delivers regulatory-compliant pharmacovigilance translations aligned with global submission standards. Our approach includes:
Linguistic Accuracy for Compliance
Native-speaking linguists with expertise in medical terminology, drug safety, and regulatory affairs ensure translations are clear, precise, and aligned with regional guidelines.
Terminology Consistency
We leverage custom glossaries, translation memory (TM), and industry-standard terminology databases to maintain accuracy across all pharmacovigilance documents.
Structured Review & Quality Control
Our ISO 17100, ISO 9001:2015, and ISO 13485:2016 certifications ensure a multi-step quality assurance process, including linguistic validation and back translation when required.
Regulatory Submission Readiness
Our translations comply with ICH E2E guidelines, MedDRA terminology, and electronic submission formats (e.g., eCTD) to facilitate seamless regulatory approval.
Confidentiality & Data Security
Compliance with GDPR, HIPAA, and industry-specific security protocols protects sensitive pharmacovigilance data throughout the translation process.
Sesen’s expertise in pharmaceutical regulatory frameworks and multilingual safety reporting enables life sciences companies to navigate global compliance requirements efficiently and mitigate regulatory risks.
Linguistic and Subject Matter Expertise
Pharmacovigilance translations require both linguistic precision and deep industry knowledge to meet regulatory and scientific standards. Sesen’s team consists of highly specialized linguists and subject matter experts with extensive experience in pharmaceutical safety, regulatory affairs, and life sciences terminology.
Life Sciences & Regulatory Experts
Our translators are native speakers with expertise in pharmacovigilance, drug safety, and medical regulations, ensuring clarity and compliance in every translation.
Medical & Scientific Terminology
We translate complex medical content with absolute accuracy, using industry-specific terminology to align with global standards such as MedDRA, ICH, and WHO drug dictionaries.
Regulatory Experience
Our linguists are well-versed in the FDA, EMA, PMDA, and NMPA submission processes, enabling seamless compliance with pharmacovigilance reporting requirements.
Sesen’s expert-driven approach ensures that pharmacovigilance translations are not only linguistically accurate but also scientifically precise and fully aligned with regulatory expectations.
Technology-Enabled Human Translation for Pharmacovigilance
Sesen integrates advanced AI-driven workflow automation with human expertise to deliver high-precision pharmacovigilance translations. Our technology optimizes linguistic consistency, terminology accuracy, and process efficiency, ensuring compliance with global regulatory standards.
AI-Assisted Workflow Automation
Our platform streamlines project management, document handling, and quality control, enabling faster turnaround times while maintaining translation accuracy.
Machine Translation Post-Editing (MTPE)
For high-volume pharmacovigilance content, MTPE enhances efficiency by allowing expert linguists to refine and validate machine-generated translations while maintaining regulatory accuracy.
Translation Memory (TM) & Terminology Management
We utilize custom TM databases and industry-specific terminology management tools to maintain consistency across pharmacovigilance documentation, reducing redundancy and ensuring regulatory alignment.
Linguistic Quality & Compliance Checks
AI-powered tools support linguistic validation and terminology consistency reviews, ensuring that translated content adheres to medical and regulatory standards.
Secure and Confidential Data Handling
Sesen prioritizes data security and compliance, adhering to GDPR, HIPAA, and industry-specific regulations to protect sensitive pharmacovigilance information.
By combining AI-driven process optimization, MTPE, and expert human translation, Sesen delivers high-quality, regulatory-compliant pharmacovigilance translations with precision, consistency, and security.
Quality Assurance and Accuracy Measures
Sesen employs a rigorous quality assurance process to deliver precise, regulatory-compliant pharmacovigilance translations. Our approach integrates specialized linguists, advanced terminology management, and structured validation processes to maintain accuracy and consistency across all submissions.
Multi-Step Review Process
Every translation undergoes a three-stage review—translation, editing, and proofreading—conducted by experienced linguists with expertise in pharmaceutical safety and regulatory compliance.
Back Translation
Critical pharmacovigilance documents are translated back into the source language to verify accuracy, detect discrepancies, and confirm alignment with regulatory expectations. For a more detailed discussion about Sesen’s back translation solutions, please click here.
Linguistic Validation
A comprehensive process involving multiple forward and back translations, reconciliation, and cognitive debriefing to ensure that translated content is scientifically precise, culturally appropriate, and easily understood by the target audience. For a more detailed discussion our linguistic validation services, please click here.
Terminology Management & Style Guides
We maintain custom glossaries, translation memory (TM), and standardized style guides to ensure consistency across adverse event reports, risk management plans, and safety data submissions.
Sesen’s comprehensive quality control framework ensures pharmacovigilance translations meet the highest accuracy, regulatory, and linguistic standards for global compliance.
The Sesen Advantage for Pharmacovigilance Translations
Sesen is a trusted partner for life sciences companies requiring high-precision pharmacovigilance translations that align with global regulatory requirements. Our expertise, technology-driven processes, and client-focused approach enable us to deliver accurate, secure, and scalable translation solutions tailored to the complexities of drug safety reporting.
Life Sciences Focus
With decades of experience in medical and regulatory translations, Sesen provides specialized expertise in pharmacovigilance, ensuring that adverse event reports, risk management plans, and regulatory submissions meet the highest linguistic and scientific standards.
Fast Turnaround & Scalability
Pharmacovigilance reporting is time-sensitive. Sesen’s agile workflows and scalable translation solutions allow us to process large volumes of safety data under tight regulatory deadlines, supporting urgent submissions without compromising quality.
Regulatory Compliance & Security
We adhere to strict security and compliance protocols, ensuring all translations align with FDA, EMA, PMDA, NMPA, and ICH standards. Our ISO 17100, ISO 9001:2015, and ISO 13485:2016 certifications guarantee quality, while GDPR, HIPAA, and industry-specific security measures safeguard confidential pharmacovigilance data.
Client-Centric Approach
Every project is managed by a dedicated project manager who works closely with clients to create customized workflows that align with specific regulatory and operational needs. Our flexible approach ensures seamless integration into existing pharmacovigilance processes.
Sesen’s commitment to precision, compliance, and efficiency makes us the preferred choice for life sciences companies looking for pharmacovigilance translation solutions that support global regulatory success.
Pharmacovigilance Translation FAQs
What are the key challenges in translating pharmacovigilance documents?
Pharmacovigilance translations require linguistic accuracy, regulatory compliance, and scientific precision. Key challenges include:
- Complex Medical Terminology: Drug safety documents contain technical, scientific, and regulatory language that must be translated with absolute precision.
- Regulatory Variability: Different agencies (FDA, EMA, PMDA, NMPA) have unique reporting formats, terminology requirements, and submission guidelines.
- Tight Deadlines: PV reporting is time-sensitive, often requiring rapid turnaround times without compromising accuracy.
- Data Confidentiality: Pharmacovigilance documents contain sensitive patient and drug safety data, necessitating strict security protocols.
Sesen’s subject matter experts, terminology management tools, and AI-driven quality assurance processes address these challenges, ensuring consistent, regulatory-compliant translations across global markets.
How does Sesen ensure compliance with global regulatory requirements?
Sesen follows a comprehensive quality assurance framework to meet FDA, EMA, PMDA, NMPA, and ICH requirements. Our compliance strategy includes:
- ISO 17100, ISO 9001:2015, and ISO 13485:2016 certifications to uphold quality and process integrity.
- Regulatory-compliant terminology management, leveraging MedDRA, ICH E2E guidelines, and client-specific glossaries.
- Structured quality control processes, including multi-step review, linguistic validation, and back translation for critical PV documents.
- Data security and confidentiality, adhering to GDPR, HIPAA, and pharmacovigilance data protection protocols.
What languages do you support for PV translations?
Sesen provides pharmacovigilance translation services in 150+ languages, covering all major global markets, including:
- European Languages: French, German, Spanish, Italian, Dutch, Polish, etc.
- Asian Languages: Chinese (Simplified & Traditional), Japanese, Korean, Thai, Vietnamese, etc.
- Middle Eastern & African Languages: Arabic, Hebrew, Turkish, Swahili, etc.
- Latin American & Emerging Market Languages: Brazilian Portuguese, Mexican Spanish, Russian, etc.
Our native-speaking, industry-expert linguists ensure that translations meet local regulatory and linguistic standards for global pharmacovigilance compliance.
How fast can you deliver pharmacovigilance translations?
Turnaround times depend on document complexity, language pairs, and volume, but Sesen provides:
- Expedited translation services for urgent pharmacovigilance reporting needs.
- Scalable workflows to handle high-volume safety data translations under regulatory deadlines.
- AI-driven project automation, allowing for faster document handling and translation consistency.
For high-priority cases, Sesen offers rush services with dedicated linguistic teams to meet tight submission timelines without compromising quality.
Do you offer back translation services for regulatory compliance?
Yes. Back Translation is a critical component of regulatory validation for pharmacovigilance. Our back translation process includes:
- Independent re-translation of the content back into the source language.
- Comparative analysis to detect discrepancies or misinterpretations.
- Reconciliation and final review to align with regulatory expectations.
For a more detailed discussion on back translation for pharmacovigilance, please click here.
