The person behind this

I am a physician working in early-stage clinical drug development (Phase 1–2) at a global pharmaceutical company. My work involves leading safety surveillance across multiple concurrent drug programs, designing safety strategies for novel mechanisms, and making the judgment calls that determine how emerging safety data shapes a drug's development path.

Before moving into clinical development, I spent years in post-marketing pharmacovigilance — the world of spontaneous reports, periodic safety reports, and regulatory signal management. Before that, I practiced clinical medicine for five years.

Why this exists

This publication exists because I believe pharmacovigilance deserves better public discourse. The field that protects patients from drug harm is poorly understood, rarely covered with nuance, and almost never written about by the people who actually do the work. I want to change that.

What I cover

Stories look backward — narrative investigations into the safety signals, regulatory decisions, and human stories that shaped modern drug safety. News covers the present — a weekly digest of the FDA, EMA, MHRA, and PRAC safety actions that practicing professionals need to know about. Trends look forward — quarterly analysis of where pharmacovigilance is heading as technology, regulation, and science evolve.

Editorial independence

All views expressed here are personal. They do not represent the views of my employer, past or present, or any organization I am affiliated with. No pharmaceutical company, CRO, or industry body has editorial influence over this publication. I do not accept sponsored content. Full details are on the Editorial Standards page.

Connect

For corrections, story tips, or collaboration inquiries: hello@patientsafety.blog.