Pharmacovigilance Translation
Rapid translation of adverse event reports and safety documentation. 24/7 support.
Time-Critical Drug Safety Translation
Our dedicated PV translation team provides 24/7 support to meet regulatory timelines for adverse event reporting.
From ICSRs to aggregate safety documents, we help maintain regulatory compliance across all markets.
Every report passes through medically trained linguists and a qualified reviewer, with MedDRA-coded terminology applied consistently so your translated narratives are ready for direct entry into safety databases and regulatory submission.
PV Documents We Translate
Comprehensive PV translation support.
Adverse Event Reporting
- Individual Case Safety Reports (ICSRs)
- Serious Adverse Event (SAE) Reports
- Follow-up Reports
- Medical History Summaries
Aggregate Safety Reports
- PSURs
- DSURs
- PBRERs
- Risk Management Plans
Safety Communications
- Dear Healthcare Provider Letters
- DHPCs
- Medical Literature Translation
- Signal Detection Reports
Rapid Turnaround for Regulatory Compliance
Meeting critical PV reporting timelines.
What You Receive
Submission-ready pharmacovigilance deliverables, formatted and documented for regulatory use.
Translated ICSRs & CIOMS Forms
Fully translated case narratives and CIOMS I forms, formatted for direct entry into your safety database.
Medical Coding Support
MedDRA-consistent terminology applied to events, indications and medications to keep coding aligned across reports.
Expedited-Reporting-Ready Files
Prioritized delivery that maps to 7- and 15-day expedited reporting timelines for serious adverse events.
Certificate & Audit Trail
A certificate of accuracy and a documented review trail to support inspections and audit readiness.
Frequently Asked Questions
What is your ICSR turnaround time?
4-hour turnaround for urgent ICSRs. 24/7 availability including weekends.
Do you have MedDRA expertise?
Yes, our PV translators are trained in MedDRA coding and terminology.
Can you handle high-volume ICSR translation?
Yes, dedicated PV teams that scale for high-volume needs.
Do you translate spontaneous and solicited reports?
Yes, all types of adverse event reports from all sources.
Request a PV Translation Quote
Get a quote within 2 hours. Contact us for urgent support.
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Need Urgent PV Translation Support?
Our 24/7 team is ready for your adverse event reporting needs.
24/7 availability - 4-hour ICSR turnaround - 150+ languages