In this episode of The Pharmacovigilance Podcast, we go inside modern PV quality systems and explore how organisations can move from reactive QMS models to proactive, AI-supported audit frameworks.

I’m joined by Stephanie Martin, Founder of SMPV Limited and a global PVQA audit expert with extensive experience supporting pharma and biotech companies through audits and inspections worldwide.

Together, we discuss:

• Why traditional, reactive QMS models no longer work

• What regulators really expect from PV quality systems today

• How to build inspection-ready, sustainable PV processes

• The role of AI in supporting audits, oversight, and continuous improvement

• Practical steps to strengthen PV quality without disrupting daily safety activities

This episode is for PV leaders, QA professionals, and anyone preparing for inspections as they navigate the future of pharmacovigilance quality.

Link to the LinkedIn profile of Stephanie Martin, Founder of SMPV Limited: https://www.linkedin.com/in/stephaniesmpv/