Pharmacovigilance – Basic
Pharmacovigilance is a study of pharmacology that deals with identifying, validating, quantifying, evaluating, and minimizing the adverse effects of therapeutic drugs, medical devices, or biologicals, thereby improving their safety. It is a united responsibility of the healthcare experts to monitor a licensed drug and identify its adverse reactions before being consumed by the patients. For someone willing to initiate his/her career in Pharmacovigilance, the entry-level job is that of a Drug Safety Associate (DSA).
Curriculum/Services
We transform individuals into medical experts by offering a curriculum designed to meet global healthcare standards.
Introduction to clinical trials/research
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Drug Discovery, Development and Preclinical Studies.
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Basics of Clinical Trials & Clinical Research Terminology & Definitions in Clinical Trials.
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Types and Phases of Clinical Trials Good Clinical Practices (GCP) and Drug Recall.
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Responsibilities of Clinical Research Professionals 21 CFR Part 11.
Performance evaluation.
Basics of pharmacovigilance
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Introduction to Various Regulatory Bodies Across the Globe.
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Introduction to Pharmacovigilance.
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Process Types of Adverse Events Case Seriousness Assessments.
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Various Guidelines Related to Pharmacovigilance.
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Various Types of Adverse Events Forms.
Performance evaluation.
Technical aspects of pharmacovigilance
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Pharmacovigilance Workflow in the PV Industry.
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Coding of Adverse Events and Drugs (Using MedDRA, WHODD and COSTART Software’s).
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Causality Assessment.
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Labelling Assessment.
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Expedited Reporting (Including SUSARS).
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Narrative Writing (Initial and Follow-Up).
Performance evaluation.
Introduction to aggregate reporting
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Basics Terminology Related to Aggregate Reporting.
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Various Types of Aggregate Reporting.
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Aggregate Reporting Timelines.
Performance evaluation.
Practical aspects related to pharmacovigilance
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Live Examples in ICSR-Clinical, PMS, Spontaneous, Literature etc...
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Pharmacovigilance Database Training.
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Three Rounds of Mock Interview Interview.
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Question and Answers Discussions.
Performance evaluation.
Online Courses
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Six Online Courses Included (From UMC)
Final Assessments
Irreplaceable Aspect
We are an outstanding training house for the healthcare industry because we offer
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Exposure to a real-time environment
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Resume Building, Interview Tips, Soft Skills, Aptitude, and Mock Interviews
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Hands-on Argus Database, MedDRA Tool, and WHO DD Tool
Requirements
The minimum eligibility criteria for the professional course in Pharmacovigilance would include either of the following:
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Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology, etc
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Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS, etc
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Any degree in Pharmacy / Pharmaceutical Sciences
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Any degree in Chemistry / Biostatistics / Bioinformatics
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Any degree in Nursing / Allied Health.
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Students in their final year of graduation for the above courses are also eligible to apply.
If you are interested to initiate a career in Pharmacovigilance with the best placement assistance, we are happy to assist you through the process.