Qualitative and Quantitative signal detection in Pharmacovigilance

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Hello All, Hope you are enjoying our articles on Pharmacovigilance and Drug Safety related topics. Today we will discuss in brief about Qualitative and Quantitative signal detection in Pharmacovigilance. Signal detection in Pharmacovigilance Signal A Signal is an “information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal …

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How to find Pharmacovigilance Job

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How to find Pharmacovigilance Job? or How to get Pharmacovigilance Job? This is the most commonly asked questions from Pharma, Life sciences and Medical professional freshers. This question is very common to both Freshers and Experienced candidates that how to know about pharmacovigilance (PV) job openings. How to find Pharmacovigilance Job in year 2022? Finding PV …

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eBOOK – Job Opportunities in Clinical Research Industry in year 2022

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Hello All, We hope this Year 2021 was challenging as well as hopeful for you. New Year 2022 is on the way and we know you Freshers are already doing hard to get your first job. There are incredible Job Opportunities in Clinical Research Industry and we are very sure that there are abundance of …

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How to prepare for Pharmacovigilance Interview in 2022?

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Hello Freshers and Experienced PV professionals, I hope you all are doing well !! The most important question that Freshers have after their graduations/post-graduations is how to prepare for Pharmacovigilance (PV) Interviews in year 2022? and same is the case for experienced PV professionals regarding what exactly to read for PV interview. How to prepare …

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Medication errors in Pharmacovigilance

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A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Mistakes in the prescribing, dispensing, storing, preparation and administration of a medicine are the most common preventable cause of undesired adverse events in medication practice and present a major public health …

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Automation and Artificial Intelligence (AI) in Pharmacovigilance

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Hello Guys, Nowadays, Automation and Artificial Intelligence (AI) in Pharmacovigilance is a “Buzz” word in Pharmacovigilance industry. Automation empowers organizations to recognize greater efficiency, quality of work and the speed at which manual tasks can be accomplished while re-directing valuable resources to focus on higher-order tasks.  Automation helps in addressing the global requirements of detection, assessment …

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Labelling in Pharmacovigilance

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Labelling is an Information on the immediate or outer packaging. For a product with an approved marketing application, any reaction which is not mentioned in the official product information is unlabeled. If it is included, it is termed labeled.  Labelling in Pharmacovigilance Reference safety information In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information …

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Basic facts about EudraVigilance and EVDAS

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Hello PV Aspirants and PV Professionals, In this article we will understand some basic facts about EudraVigilance and EVDAS (EudraVigilance Data Analysis System). EudraVigilance EudraVigilance database EudraVigilance is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). …

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Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA)

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Hi All, Let’s understand about Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA). Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA) Pharmacovigilance Agreements (PVAs) A pharmacovigilance agreement (PVA) is a written agreement between the marketing authorisation holder (MAH) and a third party (to which the MAH has shared or activities regarding or impacting pharmacovigilance), which outlines the responsibilities …

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Understand Basics of MedDRA in 5 minutes

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Hello Guys, In this article we will see some basics of MedDRA (Medical Dictionary for Regulatory Activities). MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. MedDRA is published by the International Council for Harmonisation, used in particular for coding cases of adverse effects in clinical study reports and pharmacovigilance …

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