Pharmacovigilance
Drug safety and ICSR case management support
Every adverse event report has to be captured, assessed and, where required, reported to authorities within strict timelines. We support each step of individual case safety report (ICSR) processing so that cases are complete, consistent and on time.
- Case sources Spontaneous, literature, partner, solicited and regulatory reports
- Typical inputs Source documents, safety database access, product information
- You receive Processed cases and timeliness and quality metrics
Overview
About Drug Safety & Case Management
Case processing starts with determining whether a report is valid — an identifiable patient and reporter, a suspect product and an adverse event. Cases are then triaged for seriousness and expectedness, entered and coded using MedDRA, summarised in a narrative, quality-checked and submitted where required.
We work to your SOPs or help define them, and track performance against reporting timelines and quality measures.
Use cases
When this service helps
Routine case processing
Ongoing handling of incoming adverse event reports.
Backlogs
Clear accumulated cases with quality controls.
Literature cases
Process cases identified through literature monitoring.
Partner reports
Handle cases received under safety data exchange agreements.
Scope
What the service covers
- Case intake, validity check and duplicate search
- Triage for seriousness, expectedness and reporting timelines
- Data entry and MedDRA coding of events and history
- Case narratives
- Causality assessment support
- Quality review and follow-up requests
- E2B(R3) submission support and reconciliation
Who does what
Medical review and final regulatory submission follow your designated responsibilities; Globaxa performs processing and supports assessment within the agreed workflow.
What makes a case valid?
At minimum: an identifiable patient, an identifiable reporter, at least one suspect product and at least one adverse event or reaction. Missing elements are sought through follow-up.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Receive and validateReports are logged, checked for validity and de-duplicated.
- TriageSeriousness, expectedness and due dates are assigned.
- ProcessData entry, coding and narrative writing.
- Review and submitQuality review, medical review and submission where required.
Deliverables
What you receive
Processed ICSRs
Complete, coded cases with narratives.
Follow-up management
Requests for missing information and updates.
Metrics
Volumes, timeliness and quality indicators.
Technical basis
Guidelines we work to
- ICH E2A and E2DDefinitions, standards for expedited reporting and post-approval safety data management.
- ICH E2B(R3)Electronic transmission format for individual case safety reports.
- MedDRAMedical Dictionary for Regulatory Activities, used for coding adverse events.
- EU GVP Module VICollection, management and submission of reports of suspected adverse reactions.
What we need from you
- Source documents and intake channels
- Access to your safety database (or agreed alternative)
- Reference safety information for each product
- Your PV SOPs and conventions
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Expedited reporting timelines are commonly 15 calendar days for serious unexpected reactions, but details — including whether non-serious cases must be reported — vary by country. We configure processes for each market’s rules.
FAQs
Drug Safety & Case Management: frequently asked questions
Do you provide a safety database?
We work in your database or a system you select. Database validation, hosting and gateway connectivity are provided by the vendor.
Can you handle cases in other languages?
Source documents in other languages can be handled with translation support; we agree this in the service scope.
How is quality controlled?
Through defined quality checks on every case and periodic quality metrics shared with you.
Talk to us about Drug Safety & Case Management
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST