Certificate Course In Pharmacovigilance

Drug safety, drug development and discovery, Terminology , adverse events,global guidelines, PV audits and case fallowup

What you'll learn
History and Evoluation of Pharmacovigilance & terminologies in Pharmacovigilance.
Drug discovery and development phases & Introduction to drug safety.
Types of adverse events & Pharmacovigilance global guidelines.
Medical dictionary for Regulatory activities(MedDRA)
Case fallow up, PV audits and inspection, Vaccine vigilance and materiovigilance
Requirements
Basic level of English and good quality of internet connection, Desktop /Laptop/Smartphone required(Since dealing with online mode)
Basic Knowledge on Pharmaceutical/ medical field
Description
-Pharmacovigilance is a sub field of Pharmacy which includes research, detection, assessment and analyzing the drugs. It is a very popular course in Medical Science. This course is suitable for the candidates who wish to join any pharmaceutical industry or pursue research in the future.-Here in this course i will provided excellent material for pharmacovigilace and there is very important interview Questions and answers also. Don't miss the valuble material . Even rural background students also understand the language mentioned in this material. All the best.- Pharmacovigilance is a continuous process accepted for safety evaluation accompanied by steps to improve safe usage of medicines.-Pharmacovigilance is considered to be one of the best career option for life science and pharmacy graduates. It mainly deals with reporting and analysing of medicine side effects and ensure drugs in the market are safe and secured-Pharmacovigilance Associate salary in India for freshers ranges between ₹ 2.2 Lakhs to ₹ 5.0 Lakhs with an average annual salary of ₹ 3.3 Lakhs.-The principal goal of pharmacovigilance is to influence safer usage of medicines. But, it faces increasing pressure to analyze more data sooner, monitor risks more broadly, and accurately report patient events globally.-Pharmacovigilance is regarded as a great career option for interested aspirants as it reflects a well-defined and growing career path. There is a faster career growth leading to managerial as well as director roles eventually along with a quite decent salary package. Here, in this article, we have highlighted different curriculum and career aspects of Pharmacovigilance. For someone willing to initiate his/her career in Pharmacovigilance, the entry-level job is that of a Drug Safety Associate (DSA). All DSAs get involved in developing various cases, checking for Minimum Safety Information (MSI), reconciliation and then following up processes, along with data entry of all information available in the document and medical coding.Eligibility Criteria for PharmacovigilanceFor aspirants to undertake a professional career in Pharmacovigilance, the minimum eligibility conditions for applying for the course are as follows:Graduate or postgraduate degree in Chemistry (subject) with securing at least 50% marks in aggregateGraduate or postgraduate degree in Pharmacy or Pharmaceutical SciencesGraduate or postgraduate degree in MedicineThe process of selection for the course is completely based on merit. Students are granted admission only if they have cleared a written examination followed by a personal interview.Required skillset for Pharmacovigilance:For any aspiring candidate to specialize and become DSS (Drug Safety Scientist), one needs to have the following skillset:Knowledge of Medical codingNarrative and Scientific writingGood understanding of medical termsBasic knowledge of regulatory affairs, ICH-GCP, and other compliancesAn eye for detailAbility to maintain meticulous recordsExcellent analytical & problem-solving skillsEffective CommunicationSystematic Approach to TasksGood interpretive skills

Overview

Section 1: Pharmacovigilance course

Lecture 1 Introduction to Pharmacovigilance training

Lecture 2 Introduction to drug safety

Lecture 3 History and Evolution of Pharmacovigilance

Lecture 4 Drug-discovery-and-development-class

Lecture 5 Pharmacovigilence Overview

Lecture 6 Terminology in Pharmacovigilance

Lecture 7 Types of adverse events

Lecture 8 Pharmacovigilance Global guidelines

Lecture 9 Sources of adverse event reports

Lecture 10 Regulatory expedited reporting requirements and timelines

Lecture 11 Minimum criteria for reporting

Lecture 12 Medical dictionary for Regulatory Activities(MedDRA)

Lecture 13 Seriousness and labelling assessment

Lecture 14 Causality assessment

Lecture 15 Narrative writing

Lecture 16 Case fallow up, PV audits and inspection, vaccine vigilance and materiovigilance

Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences,Graduate or postgraduate degree in Medicine,Graduate or postgraduate degree in Chemistry (subject) with securing at least 50% marks in aggregate