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Fast Track Advanced Post Graduate Diploma in Pharmacovigilance (Classroom Program)

Course Overview

Clinical research and Pharmacovigilance is rapidly growing industry globally with growth rate of over 40% per annum. A market report published by Transparency Market Research, “Pharmacovigilance Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 - 2020” estimated global pharmacovigilance market to reach USD 6,104.1 million in 2020. With the increase in public concern for the early detection of drug disasters, greater pressure is mounting on pharmaceutical industry to employ persons with sound knowledge of clinical research and pharmacovigilance. The pharmaceuticals companies are now strictly complying with the guidelines set for Good Pharmacovigilance Practice (GPvP) to avert drug withdrawal as well as maintain their reputation and position in the global market.

Pharmacovigilance market is witnessing rapid growth in Japan, South Korea, Malaysia, Thailand, India and China due to large skilled workforce and constant challenge to harmonize pharmacovigilance system in developing economies. This impressive growth of the pharmacovigilance market is attracting BPOs, KPOs and CROs, supported by international funds, to the market.

India due to its strategic positioning, industrial friendly governance and abundance working population, offers a good off shore option for global drug companies for their pharmacovigilance activities. Covance, Inc., PAREXEL International Corporation, Quintiles Transnational Holdings, Inc., F. Hoffmann-La Roche Ltd., Cognizant Technology Solutions, Accenture plc, Pharmaceutical Product Development, LLC, (PPD), GlaxoSmithKline plc, Novartis International AG, and Wipro Limited are the major players operating in the pharmacovigilance market. These companies focus on monitoring proper documentation of adverse drug reactions, monitoring and regulating proper drug usage and identifying the proper drug administration levels – the basic tenets of pharmacovigilance. The trained persons are offered the positions of Drug Safety Associate, Drug Safe Scientist, Aggregate Report Scientist, Team Leaders and much more. BII, Noida has been at the forefront of providing trainings in Pharmaceutical, clinical research and pharmacovigilance and providing solutions to the life sciences industry for the last fifteen years. We have successfully complete the 20 training sessions and our students have been placed with the leading pharmaceutical companies, CROs, KPOs and other clinical research organizations.

Advantage of Studying at BII, Noida

2 months (8 weeks) comprehensive classroom program on Pharmacovigilance (PV) with regular lecture and hands on sessions taken by experts – both full time and visiting senior faculty with a batch size of 15 persons.

Eligibility: MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharm, Graduate/Post Graduate Degree in Life Sciences, Mathematics, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and Hospitals.

Program Details :

  • Overview of Pharmacovigilance.

  • Application of Pharmacovigilance with Key    Terms & Terminologies.

  • General & Systemic Principles of Pharmacology.

  • Regulatory Guidelines & Laws in    Pharmacovigilance.

  • ICSR.

  • Medical Dictionary for Drug Regulatory Activities    MedDRA.

  • Diagnosis And Management of Adverse Drug    Reactions.

  • AE/ADR Reporting Systems & Forms.

  • Medical Evaluation of Adverse Events.


  • Scientific and Narrative Writing.

  • Expedited Reporting procedures and    Requirements.

  • Periodic Safety Update Reports (PSURs) For    Marketed Drugs (ICH E2C).

  • Signal Detection Tools.

  • Quality System in Pharmacovigilance.

  • SOPs in Pharmacovigilance.

  • Pharmacovigilance Database.

  • An Overview of Pharmacovigilance Softwares.

Entry Level Career Options Upon Completion of the Program:

  • Pharmacovigilance Officer/ Drug Safety Associate

  • Pharmacovigilance Executive/Specialist

  • Pharmacovigilance Manager/ Team leader.

Registration Fee

Registration fee is Rs 1000.

Program Fee

Course Fee is Rs 40000.

Program Duration

2 months.

Download The Application Form

For further details and enquiries

Call: 0120-4320801/02
Mob: 09810535368,9818473366

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