What changes when a pharmacovigilance leader moves from a mature, legacy-heavy portfolio to a young, fast-growing one — and what does PV leadership actually look like once you strip away the checklists?

In this milestone first-guest episode of What's Next in PV, Tereza Korecká and Jan Kolouch sit down with Pav Rishiraj, Head of Pharmacovigilance at Celltrion and Chair of the ABPI Pharmacovigilance Expert Network. After nearly a decade across big pharma and most recently Ipsen as Director of PV and UK QPPV, Pav shares what actually surprised him in his first 100 days in a very different kind of organization.

The conversation covers:

• Why scaling PV isn't about adding more people and process, and how systems thinking prevents unnecessary complexity
• What actually differs in biosimilar PV versus small molecules and novel therapeutics
• Why pharmacovigilance is "training rich but education poor" — and the real difference between training and competency
• How to build AI governance around explainability, traceability, and human-in-the-loop oversight, with lessons from a real-world system outage
• What "predictive safety" concretely means for case processing and signal management, beyond the buzzword
• What separates a strong PV specialist from someone ready to lead the function
• Where PV is headed in the next five years, and why ten-year predictions are not worth making yet

This is a practical conversation for PV leaders, aspiring leaders, and anyone trying to figure out how much of their team's future work will still be human.

Hosted by Tereza Korecká and Jan Kolouch | Guest: Pav Rishiraj, Head of Pharmacovigilance, Celltrion

Keywords:
pharmacovigilance, PV leadership, biosimilars, predictive safety, AI in pharmacovigilance, AI governance, human in the loop, signal detection, PSUR, competency-based leadership, systems thinking, ABPI, Celltrion

(00:00) - Intro music and episode introduction

(01:02) - What surprised Pav most in his first 100 days at Celltrion

(03:19) - How portfolio age and maturity change PV staffing and scaling

(09:50) - Biosimilar PV complexity vs. small molecules and novel therapeutics

(12:02) - PV leadership: building a team that functions as one unit, not a checklist

(13:52) - "We are education poor and training rich": training vs. education

(17:09) - Trust, explainability, traceability, and AI governance

(18:02) - What happens when it goes wrong: the UK air traffic control (NATS) outage

(23:35) - The aviation analogy: human in the loop, human in command(25:23) - From reactive to predictive safety: what "predictive" actually means

(33:19) - Technical vs. non-technical skills, and the CEO test

(35:43) - Pav's personal turning point: the PSUR, the CD-ROM, and "is this it?"

(43:15) - Pharmacovigilance 2.0, or already 3.0? The 5-year AI outlook

(51:23) - The biggest mindset shift: from insular thinker to systems thinker(55:37) - Closing remarks and thanks