Pharmacovigilance
Adverse event assessment and safety reporting
Collecting adverse events is only the start; they must be assessed and reported in a way that reveals the product’s safety profile. We support the medical and scientific assessment of cases, expedited reporting and the periodic aggregate reports that authorities require.
- Reports Expedited ICSRs, PSUR/PBRER, PADER, DSUR, national periodic reports
- Typical inputs Case data, sales/exposure data, reference safety information
- You receive Assessed cases and submission-ready aggregate reports
Overview
About Adverse Event Assessment & Reporting
Assessment considers seriousness, expectedness against the reference safety information and the likelihood of a causal relationship. Aggregate reports then evaluate all safety data for a period — cases, literature, exposure, studies and signals — to conclude whether the benefit–risk balance remains favourable.
We prepare aggregate reports in the format each authority requires and support the scientific evaluation that underpins them.
Use cases
When this service helps
Periodic safety reports
PSUR/PBRER or national reports due on a fixed schedule.
US periodic reports
PADERs for products marketed in the United States.
Clinical development
Development safety update reports (DSURs) for products in trials.
Safety signals
Evaluation of potential signals emerging from case data.
Scope
What the service covers
- Seriousness, expectedness and causality assessment support
- Expedited reporting assessment and timelines
- PSUR/PBRER preparation (ICH E2C(R2))
- PADER preparation (US) and national periodic reports, including India
- DSUR preparation (ICH E2F)
- Signal evaluation and benefit–risk discussion support
Who does what
Final medical judgement and sign-off rest with your designated medically qualified person or QPPV. Globaxa prepares reports and supports the scientific evaluation.
What is the difference between a PSUR and a PBRER?
The PBRER (ICH E2C(R2)) replaced the earlier PSUR format and places more emphasis on cumulative benefit–risk evaluation. Many authorities still use the name “PSUR” for reports in the PBRER format.
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.
- Plan the reportData lock point, scope and data sources are confirmed.
- Collect dataCases, exposure, literature and study information.
- EvaluateSafety data are analysed and signals assessed.
- Write and reviewThe report is drafted and reviewed with you.
Deliverables
What you receive
Aggregate safety reports
PSUR/PBRER, PADER, DSUR or national formats.
Assessment records
Documented evaluation of cases and signals.
Reporting calendar
Schedule of upcoming periodic reports by market.
Technical basis
Guidelines we work to
- ICH E2C(R2)Periodic benefit–risk evaluation report (PBRER).
- ICH E2FDevelopment safety update report (DSUR).
- 21 CFR 314.80 (USA)Post-marketing reporting of adverse drug experiences, including PADERs.
- India: NDCT Rules, 2019Periodic safety update reports for new drugs: six-monthly for the first two years after approval, then annually for the following two years.
What we need from you
- Case listings for the reporting period
- Sales or exposure data
- Reference safety information and previous reports
- Clinical study and literature information
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Periodic reporting schedules differ by market and product age. We maintain a reporting calendar so that no due date is missed.
FAQs
Adverse Event Assessment & Reporting: frequently asked questions
Can you prepare reports for several markets at once?
Yes. A core report can often be adapted for several authorities with national appendices.
Do you provide signal detection?
We support signal detection and evaluation using your case data and literature; the method depends on case volume.
Who signs the report?
Your QPPV or designated responsible person signs off the report.
Talk to us about Adverse Event Assessment & Reporting
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