Every pharmacovigilance system runs on a safety database — the central engine where every ICSR is entered, processed, and reported. But choosing, validating, and maintaining that database is one of the most consequential infrastructure decisions a biotech will make, and one of the most common sources of inspection findings when it is done badly.

In Episode 6 of What's Next in PV, Tereza Korecka speaks with Jan Kolouch and Vojtech Kvita from NextPV Services about how to approach the safety database decision end to end:

• What a safety database actually does inside the PV system, and when a company can function without one
• How vendor choice depends on ICSR volume, functionality, region, and budget — not just brand name
• Build vs. buy vs. outsource: control, cost, and who really owns your data in each model
• What GAMP 5 and EU Annex 11 validation actually requires: URS, IQ/OQ/PQ, and change control
• Practical setup steps: dictionaries, workflows, SOPs, and EudraVigilance gateway testing
• What triggers a database migration, and why it is one of the most error-prone PV projects
• Why due diligence, not the vendor's brand, determines whether the system holds up at inspection

This is a practical conversation for PV, QA, IT, and biotech leaders selecting, validating, or migrating a safety database.

Hosted by Tereza Korecka | Guests: Jan Kolouch and Vojtech Kvita, NextPV Services

(00:00) - Intro music and episode introduction(00:31) - Opening and guest greetings(00:41) - Today's topic: safety databases(00:58) - What a safety database does inside the PV system(02:16) - Do you actually need one? Volume, PSURs, and reporting obligations(03:26) - Overview question: which vendors do companies choose from(03:51) - Main selection factors: volume, functionality, region, and budget(07:45) - Large vs. small organizations: enhanced functionality vs. practicality(11:26) - Build, buy, or outsource: framing the decision(11:59) - The build option, database ownership, and vendor-managed models(16:46) - Why building your own database is rare in practice today(18:21) - GAMP validation: what the process actually looks like(19:00) - URS, FS, IQ/OQ/PQ, GAMP 5, EU Annex 11, and the EU AI Act(23:21) - Beyond validation: what companies trip up on at setup(23:52) - Database setup: dictionaries, workflows, SOPs, and EudraVigilance gateway testing(29:22) - Changing databases: what actually triggers a migration(29:46) - Migration scenarios: E2B exports, script migration, and data enrichment(34:27) - When migrations slip: deviations, mitigation, and inspections(36:54) - Closing advice for biotechs facing a database decision(37:34) - Operating model, timeline buffers, and post-launch monitoring(42:18) - Due diligence as the thread through the whole process(45:23) - Migration usually happens alongside the day job(46:20) - Why it helps to have an internal database point person(47:33) - Closing remarks

Keywords:
pharmacovigilance, safety database, Oracle Argus, ArisGlobal LSMV, Veeva Vault Safety, GAMP 5, EU Annex 11, database validation, database migration, EudraVigilance gateway, ICSR, PV system, biotech pharmacovigilance