We provide 24/7 SUSAR translation with standard turnaround of 24 hours for 15-day SUSARs and same-day/12-hour delivery for 7-day fatal/life-threatening SUSARs. We maintain dedicated PV linguist teams on standby for all major language pairs, ensuring that safety signals reach regulatory authorities within required ICH E2A timelines.
Drug Safety & Pharmacovigilance
Drug Safety & PharmacovigilanceTranslation Services
Day Translations provides 24/7 pharmacovigilance translation services for pharmaceutical companies, CROs, and safety departments — covering SUSARs, DSURs, PSURs, PBRERs, and all ICH E2A–E2F safety reporting documents with rapid turnaround in 500+ languages.
ISO 17100 CertifiedICH E2A–E2F · EudraVigilance24/7 SUSAR Turnaround
ISO 27001 information security · HIPAA-aligned · GSA-approved vendor
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Safety Documents
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Years
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PV Clients
0/7
SUSAR Availability
Our Services
Drug safety & pharmacovigilance translation services.
Specialized translation for every document type in the drug safety & pharmacovigilance sector.
SUSAR
SUSAR Translation (24/7)
Suspected Unexpected Serious Adverse Reaction reports translated within 24 hours, with same-day expedited options. Dedicated PV linguist teams on standby for all major language pairs.
DSUR
Development Safety Update Reports
Annual DSUR translation for all active clinical programs, meeting ICH E2F requirements and FDA/EMA submission timelines with version control and TM consistency.
PSUR/PBRER
PSUR & PBRER Translation
Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports translated for EMA, FDA, and global submissions, with full audit trail and regulatory compliance.
ICSR
Individual Case Safety Reports
MedWatch, CIOMS I, and EudraVigilance ICSR translation for global adverse event reporting, including narrative translation and MedDRA coding support.
RMP
Risk Management Plans
EU Risk Management Plans (RMPs) and FDA Risk Evaluation and Mitigation Strategies (REMS) translated for regulatory submissions and post-approval updates.
Signal Mgmt
Signal Management Documentation
Signal detection reports, signal assessment documentation, and benefit-risk evaluation materials translated for global pharmacovigilance programs.
PV SOPs
Pharmacovigilance SOPs
PV standard operating procedures, pharmacovigilance system master files (PSMF), and quality management documentation translated for global PV operations.
Patient Narratives
Patient Narratives & Case Reports
Clinical case narratives, patient safety narratives, and serious adverse event case reports translated with medical accuracy for regulatory submissions.
Regulatory Compliance
Built for global regulatory requirements.
Every translation is designed to meet the specific requirements of the target regulatory authority.
ICH E2A
Clinical Safety Data Management
ICH E2A guideline on definitions and standards for expedited reporting of adverse drug reactions — governing SUSAR reporting timelines and content requirements globally.
ICH E2F
Development Safety Update Reports
ICH E2F guideline on the structure and content of Development Safety Update Reports (DSURs) — applicable to all active clinical development programs.
EU Pharmacovigilance Legislation
EMA Safety Reporting
EU pharmacovigilance framework under Regulation (EU) No 1235/2010 and Directive 2010/84/EU, including EudraVigilance reporting and PSUR submission requirements.
FDA 21 CFR Part 312
IND Safety Reporting
FDA regulations governing IND safety reporting, including 15-day expedited reports and annual IND safety reports under 21 CFR Part 312.32.
MedDRA Terminology
Medical Dictionary for RA
Medical Dictionary for Regulatory Activities — the international medical terminology standard for adverse event coding in pharmacovigilance and clinical trial safety reporting.
ICH E2C(R2)
Periodic Benefit-Risk Reports
ICH E2C(R2) guideline on Periodic Benefit-Risk Evaluation Reports (PBRERs) — the global standard for post-marketing safety reporting replacing PSURs.
Why Day Translations
The drug safety & pharmacovigilance partner trusted globally.
Pharmacovigilance translation operates under some of the most demanding time constraints in the pharmaceutical industry. SUSAR reports must be submitted to regulatory authorities within 7 days (fatal/life-threatening) or 15 days (other serious unexpected reactions) of the sponsor's awareness — and these timelines apply globally, across all markets where the drug is under investigation. Day Translations maintains 24/7 pharmacovigilance translation capability with dedicated PV linguist teams on standby for all major language pairs.
Our pharmacovigilance translation practice is staffed by linguists with advanced degrees in medicine, pharmacology, and clinical pharmacology — professionals who understand the clinical significance of adverse events, the MedDRA coding system, and the regulatory requirements of ICH E2A, E2F, and E2C(R2). We do not use general medical translators for pharmacovigilance documents. The clinical accuracy of a SUSAR narrative can directly influence a regulatory authority's assessment of a drug's benefit-risk profile.
For global pharmacovigilance programs, Day Translations provides centralized PV translation management with regional linguistic expertise. We have managed PV translation programs covering FDA, EMA, PMDA, Health Canada, TGA, and ANVISA in parallel — using shared Translation Memories and MedDRA-aligned terminology databases to ensure consistency across all safety reports in a program. Our PV project managers are available around the clock to receive urgent safety documents and mobilize translation teams immediately.
Our pharmacovigilance translation services extend beyond individual case safety reports to cover the full spectrum of PV documentation: Risk Management Plans (RMPs), Pharmacovigilance System Master Files (PSMFs), signal management documentation, and PV standard operating procedures. We also provide translation support for EudraVigilance submissions, MedWatch reports, and CIOMS I forms — ensuring that safety signals reach regulatory authorities in the correct format and within required timelines.
Key Capabilities
- 24/7 SUSAR translation (7-day and 15-day timelines)
- DSUR, PSUR, and PBRER translation programs
- EudraVigilance and MedWatch ICSR translation
- MedDRA-aligned PV terminology management
- Risk Management Plan (RMP/REMS) translation
- Pharmacovigilance SOP and PSMF translation
- Signal management documentation translation
- Multi-market simultaneous PV submissions
Who We Serve
Serving the full drug safety & pharmacovigilance ecosystem.
Pharmaceutical Safety Departments
In-house pharmacovigilance departments at pharmaceutical and biotech companies requiring 24/7 safety translation for global PV programs.
- 24/7 SUSAR translation
- DSUR/PSUR/PBRER translation
- EudraVigilance ICSR translation
- RMP and REMS translation
- PV SOP and PSMF translation
CRO Safety Services
Contract Research Organizations providing pharmacovigilance services to pharmaceutical sponsors, requiring rapid-turnaround safety translation for global studies.
- SUSAR translation (7/15-day timelines)
- Clinical trial safety report translation
- Regulatory submission support
- MedDRA coding support
- Multi-sponsor PV programs
PV Consulting Firms
Pharmacovigilance consulting firms supporting pharmaceutical clients with global safety reporting, signal management, and regulatory compliance.
- Safety signal documentation
- Benefit-risk evaluation reports
- Health authority safety queries
- PV audit documentation
- Regulatory intelligence translation
Our Process
Six-step pharmacovigilance translation process.
01
Safety Document Triage
PV specialist immediately classifies document urgency (SUSAR 7-day, 15-day, or standard) and mobilizes appropriate linguist team.
02
PV Terminology Alignment
MedDRA-aligned terminology database loaded, client-specific PV glossary applied, and adverse event terms verified for consistency.
03
Expert PV Translation
Medical translator with pharmacovigilance background produces translation with clinical accuracy and MedDRA terminology compliance.
04
Medical Review
Second qualified medical linguist independently reviews for clinical accuracy, MedDRA coding consistency, and regulatory compliance.
05
QA & Timeline Verification
QA review confirms regulatory timeline compliance and document completeness before delivery.
06
Expedited Certified Delivery
Final document delivered with Certificate of Translation and full audit trail, with regulatory submission support available.
FAQ
Frequently asked questions.
Yes. We translate Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Periodic Benefit-Risk Evaluation Reports (PBRERs) for FDA, EMA, PMDA, and all global regulatory markets. We maintain client-specific Translation Memories and PV terminology databases to ensure consistency across all annual safety reports in a program.
All pharmacovigilance translations use MedDRA-aligned terminology databases maintained in all major languages. Our PV translators are trained in MedDRA coding and understand the hierarchical structure of System Organ Classes, High Level Terms, Preferred Terms, and Lowest Level Terms. We ensure that adverse event terms are translated consistently with the MedDRA coding applied in the source document.
Yes. We translate Individual Case Safety Reports (ICSRs) for EudraVigilance, MedWatch (FDA), and other global pharmacovigilance databases. We translate both the structured data fields and the clinical narrative sections of ICSRs, ensuring that the translated report accurately reflects the original case information.
Yes. We specialize in multi-market PV translation programs and have managed global safety reporting programs covering FDA, EMA, PMDA, Health Canada, TGA, ANVISA, and NMPA in parallel. We use centralized Translation Memories and MedDRA-aligned terminology databases to ensure consistency across all safety reports in a program.
Yes. We translate EU Risk Management Plans (RMPs) for EMA submissions and FDA Risk Evaluation and Mitigation Strategies (REMS) documentation. Our PV specialists understand the specific content requirements for RMPs under EU pharmacovigilance legislation and REMS under FDA FDAAA.
All pharmacovigilance projects are handled under strict confidentiality agreements and HIPAA Business Associate Agreements where applicable. We use encrypted file transfer, role-based access controls, and comprehensive audit trails. Patient identifiers are handled in accordance with ICH E6(R3) and applicable data privacy regulations (GDPR, HIPAA).
Yes. We translate pharmacovigilance audit documentation, including audit reports, CAPA documentation, and regulatory inspection responses. Our PV specialists understand the specific requirements of FDA, EMA, and PMDA pharmacovigilance inspections and can provide rapid-turnaround translation for inspection-related documents.
Ready to advance your drug safety program?
Contact our drug safety & pharmacovigilance translation specialists. We respond within 15 minutes during business hours.
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