Pharmacovigilance – Basic

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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


  • Drug Discovery, Development and Preclinical Studies.
  • Basics of Clinical Trials & Clinical Research Terminology & Definitions in Clinical Trials.
  • Types and Phases of Clinical Trials Good Clinical Practices (GCP) and Drug Recall.
  • Responsibilities of Clinical Research Professionals 21 CFR Part 11.
  • Performance evaluation.




Basics of pharmacovigilance


  • Introduction to Various Regulatory Bodies Across the Globe.
  • Introduction to Pharmacovigilance.
  • Process Types of Adverse Events Case Seriousness Assessments.
  • Various Guidelines Related to Pharmacovigilance.
  • Various Types of Adverse Events Forms.
  • Performance evaluation.




Technical aspects of pharmacovigilance


  • Pharmacovigilance Workflow in the PV Industry.
  • Coding of Adverse Events and Drugs (Using MedDRA, WHODD and COSTART Software’s).
  • Causality Assessment.
  • Labelling Assessment.
  • Expedited Reporting (Including SUSARS).
  • Narrative Writing (Initial and Follow-Up).
  • Performance evaluation.




Introduction to aggregate reporting


  • Basics Terminology Related to Aggregate Reporting.
  • Various Types of Aggregate Reporting.
  • Aggregate Reporting Timelines.
  • Performance evaluation.




Practical aspects related to pharmacovigilance


  • Live Examples in ICSR-Clinical, PMS, Spontaneous, Literature etc...
  • Pharmacovigilance Database Training.
  • Three Rounds of Mock Interview Interview.
  • Question and Answers Discussions.
  • Performance evaluation.




Online Courses


  • Six Online Courses Included (From UMC)
  • Final Assessments




Irreplaceable Aspect

We are an outstanding training house for the healthcare industry because we offer

  • Exposure to a real-time environment
  • Resume Building, Interview Tips, Soft Skills, Aptitude, and Mock Interviews
  • 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:

  • Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology, etc
  • Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS, etc
  • Any degree in Pharmacy / Pharmaceutical Sciences
  • Any degree in Chemistry / Biostatistics / Bioinformatics
  • Any degree in Nursing / Allied Health.
  • 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.

Download the course pdf for a detailed understanding before you begin your Pharmacovigilance Training with us!