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Proficiency Program in Pharmacovigilance

Course Overview

With the globalization of the pharmaceutical industry, increased use of medicines and public awareness of safety issues have come forth. India is the fourth largest producer of pharmaceuticals in the world and there is a surfeit of drug brands-more than 6,000 licensed drug manufacturers and over 60,000 branded formulations emerging as a preferred hub for clinical trials and to carry out post marketing surveillance i.e. of the approved drugs. Pharmacovigilance is particularly important in the first few years after launch, when knowledge of the safety profile is based on exposure to a much wider range of patients than is possible during clinical trials.

Pharmacovigilance in India is gaining momentum within the arena of Research and Development. As Pharmacovigilance is becoming an important part of drug development as it deals with the patients’ safety. Keeping this in mind, Bioinformatics Institute of India has designed a proficiency program on Pharmacovigilance.

"This program will increase the knowledge and importance of quality assurance amongst clinical research professional, which eventually would help in increasing the quality of clinical trials in India".

Course Objectives

The course will help participants acquire a basic understanding of the concepts and practice of pharmacovigilance. The course would sensitize the students and equips them with knowledge on Pharmacovigilance practices worldwide and on the Indian scenario in detail. The objectives of the course are as follows:

  • To enable participants to understand issues surrounding the risks and benefits of drug use in humans     including the cause, manifestations and consequences of adverse drug effects (ADEs).

  • The manner in which ADRs are detected and monitored, and the related historic and legal frameworks.

  • To introduce participants to fundamental statistical, compliance and regulations concepts and methods.

Course Modules

  • Module I - Pharmacovigilance, Risk Management, and Compliance to Clinical Safety

  • Module II - Adverse Drug Reaction, Signal Detection & Reporting

  • Module III - Clinical Trials and Regulations

  • Module IV - Signal Analysis and Pharmacovigilance Regulation

  • Module V - Pharmacovigilance Management and Importance

  • Research Study

Career Opportunities

The potential opportunities and the growth prospects in the field of pharmacovigilance are huge. The principal role of a Pharmacovigilant officer starts right from the start of preclinical studies and continues even after post marketing of the drug as drugs are evaluated for toxicity in a limited group of patients before marketing. He would be responsible for the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem both long term and short term side-effects of medicines; thereby improving the safety of drugs.

  • Clinical Pharmacovigilance Officer

  • Clinical Pharmacovigilance Associate

  • Regulatory Affairs Associate

  • Pharmacovigilant Monitor

  • Pharmacovigilance Manager

  • Analyst

Eligibility: Any Science Graduate

Admission Procedure
  • Submission of Application.

  • Enclosures.

Program Duration: The program duration is 6 months.

Program Fee

BII Program Participation Fee for this program is Rs. 13,000 for participants based in India / USD 900 for Overseas participants.

Download the Application Form

Examination Fees: Every student has to pay Rs. 500 per module as examination fees. Examination fee for Overseas participants is USD 30 per module

Download the Examination Form

Re-registration: Only once the candidate will be allowed to re-register himself for the course by paying the 50% of the course fee.

Download the Re-registration Form

Mode of Payment
Payment can be made through:
Demand Draft/Cheque in favor of Bioinformatics Institute of India at Delhi/Noida or NEFT.
NEFT (HDFC bank account details)
Account Name: Bioinformatics Institute of India
Bank Address: Sector 63 Gautam Budh Nagar Noida (U.P)
Current Account Number: 5020 0003 7096 35
IFSC Code: Hdfc0000975
MICR Code: 110240129
Branch Code: 000975

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