Tag: PSMF

By Vigilare Biopharma December 30, 2025Pharmacovigilance

Qualified Person Responsible for Pharmacovigilance (QPPV) in the UK & EU

Do you know? As per the EU Regulation 2025/1466 and evolving signal-monitoring expectations, accountability of the Qualified Person Responsible for Pharmacovigilance (QPPV) towards EudraVigilance monitoring, PSMF data accuracy, audit-readiness, etc., is becoming significant and mandatory.

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By Vigilare Biopharma December 17, 2025Pharmacovigilance

Continued Regulatory Guidance on Pharmacovigilance: Aligning with Best Practices and Data Transparency in 2026

The pharmacovigilance (PV) landscape is evolving rapidly, triggered by increasing data volumes, global collaborative efforts, and demanding data transparency expectations. Given the scenario, 2026 is expected to become a defining year for the Pharmaceutical industry

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Deep Dive: Best Practices for Compiling a Robust Pharmacovigilance System Master File (PSMF)
By Vigilare Biopharma October 21, 2025Pharma

Deep Dive: Best Practices for Compiling a Robust Pharmacovigilance System Master File (PSMF)

Introduction In today’s highly regulated pharmaceutical environment, a company’s pharmacovigilance system defines its credibility, transparency, and commitment to patient safety. At the heart of this system lies the Pharmacovigilance System Master File (PSMF) — a

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