Green Pharmacy Is Becoming a Core Drug Safety Issue
Pharmaceutical pollution is no longer a niche environmental concern. It is becoming a serious regulatory, scientific, and professional issue, and pharmacovigilance professionals are increasingly well placed to help lead the response. For years, traces of medicines have been detected in rivers, lakes, wastewater, and even drinking water. What has changed is not the existence of […]
Most compliance teams treat audit preparation like a fire drill. Inspectors announce, panic sets in, everyone scrambles to locate documents that should have been organized months ago, and leadership spends two weeks pretending the gaps were never there. There is a better way to run this. I spent time mapping Stephen Covey’s 7 Habits of […]
The short answer, for most organisations, is: not really. Not yet. AI is already inside pharmacovigilance and medical information workflows. Case intake tools, literature screening software, enquiry response drafting, signal detection platforms. It didn’t arrive with fanfare. It arrived quietly, embedded in systems people use every day. And in many cases, the professionals using those […]
In drug safety, the question for pharmaceutical companies isn’t whether to outsource anymore—it’s how to do it right. Pharmacovigilance outsourcing has moved well beyond simple case processing into something closer to a strategic partnership that handles everything end-to-end. Drawing on insights from industry experience, this guide covers the shift to full-service models, the compliance pitfalls […]
Pharmacovigilance tracks drug safety data to ensure medications help patients more than they hurt them. Any organization handling this work needs a solid Quality Management System to meet their regulatory obligations and actually do the job right. What a Pharmacovigilance QMS Really Is The QMS sits within your broader pharmacovigilance setup. It maps out who […]
Clinical trials in life-threatening diseases carry tremendous ethical weight. When you’re testing a new treatment on patients who may have run out of options, you need to know—fast—whether that treatment helps or harms. This is where Data Safety Monitoring Boards (DSMB) or data monitoring committees (DMC or iDMC) come in, and more specifically, why auditing […]
In the world of Pharmacovigilance, the Drug Safety Mailbox is far more than an email address. It is the nerve center of patient safety—the first point of contact where patients, healthcare professionals, and partners report adverse events, product quality issues, and medical inquiries. Yet for many organizations, this critical mailbox has become a bottleneck. With […]
When a patient receives a prescription, they see only the tip of the iceberg—a simple medication meant to treat their condition. But beneath the surface lies a vast, complex infrastructure dedicated to keeping them safe. This powerful metaphor captures the essence of pharmacovigilance and the hidden layers of work that protect patients every day. The […]
The Audit Question That No One Wants to Answer In my years conducting audits, I often paused at the Business Continuity Plan (BCP) section and asked a simple, uncomfortable question: “If the internet stops working completely for 48 hours, how will you submit your expedited safety reports to the regulatory authorities?” The answers were often […]
Antimicrobial Resistance (AMR) is often called the “silent pandemic.” It is not just a future threat; it is happening now, affecting millions of lives globally. While we often think of AMR as a clinical or public health issue, there is a powerful, underutilized weapon in our arsenal: Pharmacovigilance. Based on the latest insights, here is […]