The Pharmacovigilance Podcast

In this episode, I speak with Daniel Kapfer, CEO of Jenly AI, about how AI is reshaping regulatory reporting and PV processes. We discuss real use cases, quick efficiency wins, and the risks you can’t ignore, including AI hallucinations and validation challenges.
The key message: AI can accelerate pharmacovigilance, but humans remain essential. The future is “human in the loop.”
What you’ll learn:
• Where AI delivers the biggest impact in PV
• How to use tools like Copilot for quick wins
• How to manage AI risks and hallucinations
• Why human expertise is still critical
📩 Contact Daniel Kapfer:
Website: www.jenly.ai
Email: [email protected]

In this episode of The Pharmacovigilance Podcast, host Julia Appelskog speaks with Sabita Mukherjee, COO and Joint Owner, Essjay Solutions Ltd & Sagittal Pharma Consulting Ltd.
Sabita shares his unusual career journey from more than 30 years in financial services to working in pharmacovigilance. Drawing on experience from two highly regulated industries, he discusses how governance, accountability, audits, and crisis management.
The conversation also explores the growing role of AI in regulated environments. Sabita and Julia discuss why explainability, human oversight, and strong governance are essential when adopting AI in pharmacovigilance, and how regulators are encouraging innovation while maintaining patient safety.
Topics covered:
• Career transition from finance to pharmacovigilance
• Differences in regulatory culture between finance and PV
• Governance and accountability in AI systems
• AI as a “copilot” rather than an “autopilot”
• Audits, explainability, and decision transparency
• Crisis management in regulated industries
A thoughtful conversation on how different regulated sectors can learn from each other and how AI can support professionals without replacing expert judgment.
🎧 Stay tuned and stay compliant.
Guest: Sabita Mukherjee, COO and JointOwner, Essjay Solutions Ltd & Sagittal Pharma Consulting Ltd
Essjay Solutions Ltd:  https://essjaysolutions.co.uk/
LinkedIn: https://www.linkedin.com/company/essjay-solutions-ltd/
Subscribe to AI in PV Newsletter Subscription Page: https://mailchi.mp/b65dd5bfa504/essjay_ai_newsletter
Sagittal Pharma Consulting Ltd: https://sagittal-pharma.com/
LinkedIn: https://www.linkedin.com/company/sagittalpharmaconsulting/
YouTube: https://www.youtube.com/@sagittalpharma

New episode of The Pharmacovigilance Podcast
Guests: Romain Clément and Olivier Merle from ArcaScience
Benefit–risk assessment is at the core of pharmacovigilance. More data, faster development timelines, increasing complexity, and rising expectations from regulators andLeadership is challenging traditional approaches that rely heavily on manual review and retrospective analysis.
In this new episode, we explore how AI is reshaping benefit–risk decision-making and what this means for senior safety professionals today.
Together with experts from ArcaScience, we discuss:
What AI actually changes in day-to-day benefit–risk work
How integrated data supports earlier and more confidentdecisions
How ArcaScience models support benefit–risk acrossdevelopment stages
How regulators are reacting to AI-supported approaches
This conversation focuses on practical realities and on how safety teams can use AI to strengthen expertise, not replace it.
🔗 Learn more & connect
ArcaScience website: https://arcascience.ai
Romain Clément on LinkedIn: https://www.linkedin.com/in/romainclement75/
Olivier Merle: https://www.linkedin.com/in/oliviermerle/
ArcaScience on LinkedIn: https://www.linkedin.com/company/arcascience/
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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/

In this episode #20 of The Pharmacovigilance Podcast, host Julia Appelskog sits down with Dr. Stephanie Jones, Founder & Chief Medical Officer of Pharmora, to trace her path from independent consultant to leading a high‑performing medical services company supporting clinical development and pharmacovigilance worldwide.
We discuss early pivots, the leadership habits that scale quality, and why “quality without compromise” became a guiding principle for sustainable growth.
We also explore how to build a values‑aligned team, deliver consistently under pressure, and win trust as a specialist partner in lifecycle safety and medical review.
Pharmora was founded in 2010 and today serves the global pharma and biotech sectors. In 2025, the company was recognised in London’s Gherkin with the Best Pharma Contract Services award at the IAE & Euro Star Global Awards, an emotional milestone for the team and a practical lesson in long‑game execution.

You’ll learn:
• How to move from freelancing to a scalable service model in pharma
• The operational meaning of “quality without compromise” and why it compounds over time
• Hiring for values, training for excellence, and building delivery capacity that clients rely on
• Advice, pitfalls, and playbooks for would‑be founders in PV, clinical, and medical affairs
Links
Dr. Stephanie Jones — LinkedIn profile linkedin.com/in/stephanie-j-jones
Pharmora Pharmora | Clinical Development support | Pharmacovigilance
IAE & Euro Star Global Awards announcement (The Gherkin, 2025) IAE Awards post