How to switch from ICSR Role to Aggregate Reporting, Signal and Risk Management Role?
This post is about How to switch from ICSR Role to Aggregate Reporting, Signal and Risk Management Role in Pharmacovigilance
Understanding PSMF and Role of QPPV in Pharmacovigilance
Hello Guys, In this article, we will see about Pharmacovigilance System Master File (PSMF) and role of Qualified Person responsible for Pharmacovigilance (QPPV). PSMF is a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products. The PSMF shall be located either at the …
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What are Special Situation Scenarios in Pharmacovigilance?
Hi All, You must have come across the term “Special Situation Scenarios in Pharmacovigilance“. Let’s see what is special situation reporting and their types in brief. Definition The special situations are non-standard medical conditions that provide valuable information about medicinal product, even when they don’t occur in association with an adverse event or medical condition. …
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E-BOOK for Pharmacovigilance Interview Preparation
Dear All, We have published an eBook for frequently asked Questions and Answers in Pharmacovigilance interview. The purpose of this eBook is to help freshers and experienced PV professionals in their interview preparation. This eBook will be helpful to understand basic concepts of PV and for revision purpose during interview time. We have included following topics …
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What is Signal in Pharmacovigilance?
Hi All, In this Article, we will see What is Signal in Pharmacovigilance? Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that …
What is Safety concern, Identified risk, Potential risk and Missing Information
Hello Guys !! In this article, we will see What is Safety concern, Identified risk, Potential risk and Missing Information. Safety concern An important identified risk, important potential risk or missing information. The safety concerns of a medicinal product are identified, characterised, and monitored in the DSUR; the RMP, and in the PSUR / PBRER. …
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What is Risk management plan and Risk management system in Pharmacovigilance?
Hello Guys, In this article, will see What is Risk management plan (RMP) or Risk management system (RMS) in Pharmacovigilance? We will also see What is Risk minimisation measure or Risk minimisation activity and Benefit-Risk Balance? RMP Risk Management Plan (RMP) is a dynamic, stand-alone document that should be updated throughout the life-cycle of the medicinal product to reflect the …
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What are Aggregate Reports in Pharmacovigilance?
Hi All, In this article we will see What are Aggregate Reports in Pharmacovigilance? Aggregate report is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide. The aggregate report examines and summarizes all existing safety experience with a medicinal product. …
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Most common Pharmacovigilance Abbreviations
Hi All, Below are the most common Pharmacovigilance (PV) Abbreviations. ADR: Adverse Drug Reaction AE: Adverse Event AEFI: Adverse Event Following Immunization AESI: Adverse Event of Special Interest aRMM: Additional Risk Minimisation Measures ATMP: Advanced Therapy Medicinal Product CCDS: Company Core Data Sheet CCSI: Company Core Safety Information CHMP: Committee for Medicinal Products for Human Use …
What are different roles in Pharmacovigilance Job?
Hello All,I hope you are doing great !!!If you are a fresher or just started your career in Pharmacovigilance (PV) then you must have a lot of queries regarding what are different roles in PV jobs and how to move into these roles? Don’t worry guys, I am here to help you. Pharmacovigilance is very dynamic process. …
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