The Next Black Box Warning Could Be Sitting in Your Queue Right Now.
Conclusion: ICSRs case assessments have ripple effect on the evolving safety profile of the IMPs. Explanation: In pharmacovigilance, there is a tendency to view Individual Case Safety Reports (ICSRs) as discrete units of work—cases that arrive, are assessed, documented, and submitted within regulatory timelines. Yet, the true significance of an individual case extends far beyond […]
“Is the pharmaceutical job market getting better?”
Wall Street Journal reported today that “The U.S. Job-Creation Machine Is Coming Back to Life” as 500,000 jobs were added to the market between March and May 2026. So, “Is the pharmaceutical job market getting better?” Not long ago, my answer was cautious. Companies were restructuring, projects were being reprioritized, and hiring managers often wanted […]
Resources Every Pharmacovigilance Professional Should Bookmark
Continuous learning is essential for success in Pharmacovigilance. Below is a curated list of trusted resources that can help professionals stay informed about regulatory updates, safety reporting requirements, coding dictionaries, signal detection, and industry trends. Regulatory Authorities U.S. Food and Drug Administration (FDA) The FDA publishes safety communications, guidance documents, inspection findings, and regulatory updates. […]
Off-Label Drug Use: Why Safety Monitoring Matters More Than Ever
This practice, known as off-label drug use, has become increasingly common across multiple therapeutic areas. While off-label prescribing can provide important treatment options for patients with unmet medical needs, it also introduces significant challenges for Drug Safety and Pharmacovigilance professionals responsible for monitoring medication safety after market approval. Basic Knowledge of Off-Label Drug Use Off-label […]
“How did the interview go?”
“How did the interview go?” — The question that stings… until it teaches you everything Last week, one of my mentees—let’s call her Priya—walked out of what she thought was a strong interview for a Drug Safety Associate role. She had done everything right on paper. ✔ Strong academic background ✔ Hands-on Pharmacovigilance exposure ✔ […]
Upcoming Trends in Drug Safety with AI/ML
The drug safety landscape is undergoing its most profound transformation in a generation. AI agents, large language models, and real-world data pipelines are reshaping how we detect, assess, and communicate safety signals — and the professionals who thrive will be those who blend deep domain expertise with technological fluency. Why Now? Pharmacovigilance was built on […]