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
Why Pharmacovigilance is the Best Career Choice?
Insights on why Pharmacovigilance is the Best Career Choice
Certificate course in Signal Detection and Management in Pharmacovigilance
Certificate course in Signal Detection and Management in Pharmacovigilance Hello All, We have launched “Certificate course in Signal Detection and Management in Pharmacovigilance”. This course is exclusively designed for Pharma students, Medical practitioners and Life science graduates. This course will be helpful to those who have ICSR and Aggregate Reporting experience in Pharmacovigilance domain and …
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Certificate course in Pharmacovigilance Aggregate Reporting
Certificate course in Pharmacovigilance Aggregate Reporting Hello All, We have launched “Certificate course in Pharmacovigilance Aggregate Reporting”. This course is exclusively designed for Pharma students, Medical practitioners and Life science graduates. This course will be helpful to those who have ICSR experience in Pharmacovigilance domain and for those who wants to learn and excel their …
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Certificate Course in Pharmacovigilance ICSR Case processing
Certificate Course in Pharmacovigilance ICSR Case processing Hello All, Check out our Pharmacovigilance (PV) course “Certificate Course in Pharmacovigilance ICSR Case processing”. This course is designed for Pharma students, Doctors and Life science graduates. This is a unique course for Fresher’s which can help them to understand Basics and Intermediate level of Pharmacovigilance (PV) concepts. …
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Black triangle products
Black triangle products In the European Union (EU), medicines that are being monitored closely by regulatory authorities are labelled with a black inverted triangle (▼) in the product information. These medicines are described as being under ‘additional monitoring’. Medicines under additional monitoring carry a black triangle symbol (an inverted equilateral black triangle; ▼) to let patients and Health Care …
Regulatory Authorities in Pharmacovigilance
Regulatory Authorities in Pharmacovigilance A regulatory authority is an autonomous enforcing body created by the government to oversee and enforce regulations regarding occupational health and safety. Regulatory Authorities play a vital role to meet the requirements of legal procedures related to drug development process in a country. The regulatory body ensures compliances in various legal and …
Pharmacovigilance Risk Assessment Committee (PRAC) and their Importance
Introduction EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines. It constitutes experts in medicines safety from regulatory authorities in Member States, scientific experts and representatives of patients and healthcare professionals, which are nominated by the European Commission. EMA supports the PRAC by providing data from clinical practice available in electronic …
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Which Pharmacovigilance Job Role is High demanding and gives High Salary packages?
Hello Pharmacovigilance Professionals and Pharmacovigilance Aspirants, 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? Which Pharmacovigilance Job Role is High demanding? Which Pharmacovigilance Job Role provides High Salary packages? Pharmacovigilance Job First of all, lets see what are the overall …
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Basics of DSUR (Development Safety Update Report)
The Development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo products under development (including marketed drugs that are under further study) among the ICH regions. Development Safety Update Report (DSUR) DIBD (Development International Birth Date) DIBD is the date of first approval (or authorisation) …
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E-Book for frequently asked QnA in Clinical Data Management (CDM) interview
Dear All, We have published an eBOOK for frequently asked Questions and Answers in Clinical Data Management (CDM) interview. E-Book for Clinical Data Management (CDM) Interview preparation The purpose of this eBook is to help freshers CDM aspirants and experienced CDM professionals in their interview preparation. This eBook will be helpful to understand basic concepts of Clinical Data …
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Understanding Basics of PADER (Periodic Adverse Drug Experience Report)
Dear PV Professionals and PV Aspirants, Today we will see some basic facts about PADER (Periodic Adverse Drug Experience Report). What is PADER? A PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug Administration (FDA) after obtaining marketing authorization approval. PADER …
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