Faculty of Clinical Research

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Executive Diploma in Pharmacovigilance


Pharmacovigilance is an inseparable part of ever growing and recession proof CR industry. Only professionally trained employees get to make their mark and reach pinnacles of success in this fast moving sector of the health care industry. Thus IGMPI targets to teach, train and polish aspirants as Clinical Research professionals with clear understanding and complete knowledge of the industry and its working.

The Executive Diploma in Pharmacovigilance aims to benefit the professionals working in the various CR industries as it is structured by experts from the industry themselves and so global coverage and understanding of the industry and its functional areas is promised.

Programme Modules :

Module 1: Introduction to Pharmacology, Clinical Trials and Pharmacovigilance

Module 2: Adverse Drug Reactions and Safety Reports

Module 3: Methodologies in Pharmacovigilance

Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance (Argus, ArisG, MedWatch, MedRA, WHODD etc.)

Module 5: Seriousness & Expectedness & Causality Assessment Criteria

Module 6: Aggregate Safety Reports

Module 7: Pharmacovigilance Regulations in Various Countries

Module 8: Pharmacovigilance Programme in India (PVPI)

Module 9: Signal Detection and Data Mining

Module 10: Pharmacovigilance of Herbal Drugs & Medical Devices

Module 11: Pharmacovigilance Compliance and Inspections

Module 12: Hands-on training on Argus, ArisGlobal, ABcube etc software platforms.

Module 13: Case Study

After pursuing this programme, a candidate will have a thorough and comprehensive insight about different types of Intellectual Property (IP) and its related statutes, Indian Copyright Law 1957 with its amendments, The Designs Act 2000, Trademarks Act 1999, Role of World Intellectual Property Organization (WIPO), WTO- TRIPS and new international treaties for dispute settlement, Patentable subject matter, Patentability Criteria, Procedure for Filing Patent Applications, Revocation, patent infringement issues with special focus on US, European and Indian IP laws and regulations. The Indian Patent Act (1970) and the present Patent Amendment Act (2005) will be discussed with examples of patents and technology transfer and progressive harmonization with international standards.

The case study based approach in Executive Diploma programme via online learning mode is designed for working professionals in full-time employment who wish to complete the programme in shorter time duration. This programme is beneficial for professionals from different streams to help them intensify their knowledge. This is a fast track and advanced programme having rigorous case studies based methodology throughout the duration.

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

Minimum time in which a student can complete this diploma programme is 6 months while a maximum of 12 months is allowed to complete the programme.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • – Assignments for all the programme modules for continuous evaluation and guidance.
  • – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
  • – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
  • – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • – All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will receive a certificate of Executive Diploma in Pharmacovigilance by Faculty of Clinical Research, IGMPI. For all the above mentioned modules elaborate programme material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical & IT giants like Covance, Bioclinica, IQVIA, PPD, Icon, Indegene, Syngene International, GSS Pharma , Novartis, Genpact, HCL, Dr Reddy’s Laboratories, TCS , Pfizer, Piramal Healthcare , Aurobindo Pharma, Shantha Biotechnics , Biological E Ltd, Accenture , Kinapse etc.

Future career prospects of Pharmacovigiliance

IGMPI offers professional and industry oriented training in Pharmacovigilance thus opening doors for entry into the industry. Executive diploma in PV adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to have sustained growth in the industry.

Executive Diploma in Pharmacovigilance is a comprehensive programme offering candidate with knowledge and practically important information about the industry type, working modalities, methodology used, techniques of quality control, drug development precisely but whole emphasis remains on Pharmacovigilance. This includes in depth study of varied types of adverse effects, serious adverse effect, adverse effect reporting regulation, documentation methods etc. With the completion of this programme the candidate gets to select from varied work areas of the industry/sector of his/her interest.

Knowing all theoretical and practical facts about post marketing surveillance, candidate feels comfortable and confident when working in the industry. Obviously experience has no match and thus efforts are made to bring in experienced professionals to present projects, take lectures and thus add to the benefits reaped from the programme. Same is true for the professionals who are already a part of the CR industry but are keen on making lateral movement in their company by shifting to other Pharmacovigilance Department.


Download Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free) , Phone: +91 11 26512850

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All existing and old students and training participants are requested to write to our Corporate Resources division on info@igmpi.ac.in along with your updated resume mentioning their Enrollment No. for registration with our Placement Cell asap, if not registered yet.


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Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

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