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Post Graduate Diploma in Pharmacovigilance


With emphasis on Pharmacovigilance, there appears huge need for adequately qualified and trained professional who could understand and take up post marketing surveillance roles in drug companies. Thus, there occurs a need of team of drug safety officers. Clearly this need is proportional to the number of new drugs being launched every year which is always increasing. IGMPI has stepped forward to tap this growing need as a professional opportunity for those keen for entering this industry.

The Post Graduate Diploma in Pharmacovigilance has been structured by experts from the industry themselves and thus comprehensive coverage and understanding of the industry and its functional areas is promised. The goal of the Post Graduate Diploma Programme is to familiarize the participant with the updated theoretical and practical aspects of the Pharmacovigilance. The diploma course has the following tempting features which are definite to benefit one to all participants of the course.

1. Better industrial training and skills,

2. Better knowledge of the industry,

3. Practical and professional training about the Industry regulations and work processes and

4. Good hold on the framework of PV industry leading to availability of best employment options.

Course 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.

Experimental Training

1. Introduction to Oracle AERS.

2. Preparation of PSUR for submission in EU.

3. MeDRA Coding.

4. Eudravigilance medicinal product dictionary.

5. Introduction to Argus.

6. WHODD Coding.

7. Signal detection and Data mining-Statistical and non-statistical.

8. Introduction to Aris G Pharmacovigilance and safety.

Experimental training along with the lectures from expert professionals will help the participant to learn the practical aspects of clinical trial process. After the course completion, the participant is expected to have extensive and up-to-date knowledge of clinical research industry and pharmacology, PSUR for adverse reaction reporting, filling process of India and International countries -NDA, INDA, EDC, CTD/eCTD, IRB, BLA and Informed Consent Form, Clinical Trial Management System (CTMS), preparation of protocol and case report forms (CRFS), etc.

Eligibility

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 duration to complete this programme is 12 months

Registration

The registration dates for this bi-annual executive programme run by the Institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course 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.

Internship

All the efforts will be made in the form of 3 months internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.

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 course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will receive a certificate of Post Graduate Diploma in Pharmacovigilance, IGMPI. For all the above mentioned modules elaborate course 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. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.

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 Pharmacovigilance Training

IGMPI offers professional and industry oriented training in Pharmacovigilance thus opening doors for entry into the industry. PG diploma in CR 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 sustain and grow in the industry.

PG Diploma in Pharmacovigilance is a comprehensive course 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 course 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 course. 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@igmpiindia.org/ 1800-103-1071 (India Toll Free) ,
+91 11 45768446 (International Students)

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