Faster Translation and Cost Savings with AI
Faster Translation and Cost Savings with AI
Pharmacovigilance Translation Services and Automation
When patient safety is on the line, every word matters. Our streamlined process translates your critical pharmacovigilance documents with unmatched accuracy, speed, and compliance, so you can focus on what matters most—protecting patient safety worldwide.
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Deliver more reliable translations for all critical safety documents quickly. We make sure your documentation is precise and ready for submission.
Pharmacovigilance Document Translations
Accurate translations of pharmacovigilance documents are essential for maintaining regulatory adherence and ensuring safety. With expertise in translating key documents across the product lifecycle, from Pharmacovigilance System Master File (PSMF) documents through to commercialization communications. Our automated translations meet the specific requirements of regulatory agencies such as the FDA, EMA, and others. This system also includes a case triage process for timely categorization and prioritization of adverse event reports.
Popular pharmacovigilance and drug safety translation projects include:
Adverse Event and Safety Reporting
- Case Report Forms (CRFs)
- Individual Case Safety Reports (ICSRs)
- Adverse Event Reports (AERs)
- Serious Adverse Event Reports (SAE Reports)
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Signal Detection and Management Reports
- Medication Error Reports
- Vaccination Adverse Event Reports
- Aggregate Signal Detection Summaries
Database Reporting and Case Management
Regulatory Submissions and Approvals
- New Drug Applications (NDAs)
- Investigational New Drug Safety Report (INDSRs)
- Investigational New Drug Reporting (INDRs)
- Pharmacovigilance Agreements (PVAs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Development Safety Update Reports (DSURs)
- Post-Marketing Surveillance Reports
- Post-Authorization Safety Studies (PASS)
- Health Authority Queries and Responses
- Common Technical Document (CTD) Sections
- Orphan Drug Designation Applications
- Variations and Amendments
Risk Management and Mitigation
- Pharmacovigilance Risk Management Plans (RMPs)
- Benefit-Risk Assessment Reports
- Field Safety Corrective Actions (FSCA) Notices
- Safety Data Exchange Agreements (SDEAs)
- Drug Safety Compliance Audit Reports
- Post-Marketing Commitment Reports
- Corrective and Preventative Action (CAPA) Reports
- Safety Signal Assessment Reports
Clinical Documentation and Reporting
- Clinical Study Reports (CSRs)
- Nonclinical Study Reports
- Aggregate Reports
- Summary of Product Characteristics (SmPCs)
- Protocol Deviation Reports
- Investigator Brochures (IBs)
- Clinical Trial Protocols
Patient and Healthcare Communications
- Product Information Leaflets
- Patient Safety Information
- Direct Healthcare Professional Communications (DHCPs)
- Dear Health Care Provider Letters (DHCP Letters)
- Medication Guides (MedGuides)
- Safety Narratives
- Public Safety Announcements (PSAs)
- Educational Materials for Healthcare Professionals
- FAQs on Adverse Drug Reactions
Operational and Procedural Documentation
- Global Pharmacovigilance Procedural Documents
- Biological Product Deviation Reports (BPDRs)
- Quality Defect Reports
- Medical Device Adverse Event Reports
- Local Safety Officer (LSO) Communications
- Pharmacovigilance SOPs (Standard Operating Procedures)
- Training Manuals for Pharmacovigilance Teams
- Vendor and Partner Compliance Reports
Frequently Asked Questions
How do you ensure translation accuracy?
Our dual-review process involves advanced neural machine learning paired with linguistic review by life sciences specialists. Dual-review ensures translations are accurate and meet regulatory compliance and industry standards.
How do you handle confidential information?
Your data will be secure as our team adheres to the highest industry standards. In addition to encrypted data handling, automated PII redaction is utilized to ensure that any personal or clinical data is carefully redacted in compliance with privacy laws (such as GDPR or HIPAA).
Can you handle large-volume projects with tight deadlines?
Yes, our global team of life sciences linguists leverages TransPerfect's proprietary translation management system to handle enterprise volumes with tight deadlines. Our infrastructure is designed to uphold the highest standards of quality, accuracy, and regulatory compliance, regardless of project size and timeline.
Do you offer support for post-market surveillance translations?
Yes, we provide comprehensive translation services for all phases of the product lifecycle, including post-market surveillance. All translations will be in compliance with global regulations for adverse event reporting, periodic safety update reports (PSURs), or risk management documentation.
What is your process for integrating translations into our existing pharmacovigilance systems?
Our translation services seamlessly integrate into your existing systems, including eTMF (electronic trial master files) and ePRO (electronic patient-reported outcome) systems. Our technical team works closely with yours for a smooth integration, reducing workflow disruptions and maximizing efficiency.
How do you handle updates or revisions to translated documents?
We provide revision support for any updates or changes to your documents, whether it’s a regulatory change or a modification to your safety reporting requirements.
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