pv

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 […]

Aviation is a prime example of an industry where lives are at stake, and it shares striking similarities with pharmacovigilance—the science of monitoring and ensuring drug safety. Both operate in highly regulated, complex environments where human factors and automation play critical roles. Here are key lessons pharmacovigilance can learn from aviation’s extensive experience. 1. Safety […]

What do you think is the single most important factor for an inspector or auditor? Believe it or not, it is ‘time’. The auditor is already hard-pressed for time and needs to find as many gaps as possible in the stipulated timeframe allocated for the audit. You cannot afford to take any chance, irrespective of […]

Pharmacovigilance is generally regarded as a cost centre in a pharmaceutical company, and the management will always be on the lookout for further reducing the costs without compromising compliance. One way to achieve this is through automation. There is a galore of automation opportunities available in patient safety. This can be simple automation or by […]

A pharmaceutical company is any commercial entity that may be associated with research, manufacturing, commercialization or distribution of medicinal products. This entity may or may not own the product license, and this factor may decide if this entity will or will not fall under the purview of pharmacovigilance regulations. That doesn’t prevent the company personnel […]

After more than two decades in the drug safety industry, I have a confession: I still have a deep, personal apprehension about using the abbreviation ‘PV’ to denote Pharmacovigilance. It’s a two-letter identity crisis, and for many of us with a clinical background, it’s a source of genuine, albeit humorous, confusion. Here is the history […]

“The best way to survive an FDA inspection is to be prepared for it!” An FDA Pharmacovigilance inspection is generally unannounced. However, if it pertains to a foreign/ Non-US site, it is likely to be a pre-announced one. What are the types of FDA Pharmacovigilance inspections? 1. Post Marketing Adverse Drug Experience (PADE) 2. Risk […]