Post Graduate Diploma/Executive Diploma in Pharmacovigilance


With emphasis on Pharmacovigilance and Pharmacoepidemiology, 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 by providing innovative regular and web-based education & training offer in Pharmacovigilance. This programme is being noticed and recognized worldwide* as an excellent means to get medicines related jobs.

The Post Graduate Diploma/Executive 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/Executive Diploma Programme is to familiarize the participant with the updated theoretical and practical aspects of the Pharmacovigilance. The diploma programme has the following tempting features which are definite to benefit one to all participants of the programme.

  • . Better industrial training and skills,
  • . Better knowledge of the industry by making the trainees familiar and able to understand the main epidemiological and statistical principles, concepts and tools that are used in pharmacovigilance practices and research
  • . Practical and professional training about the Industry regulations and work processes and
  • . Good hold on the framework of PV industry leading to availability of best employment options.
  • . To master basics concepts on how to communicate written and oral scientific results

Programmme Structure :

Module 1: Introduction to Pharmacology, Clinical Trials, Pharmacovigilance and Pharmacoepidemiology

  • Basics of Pharmacology
  • The Clinical Research Industry
  • Phases of Clinical Trials
  • Pharmacovigilance methods
  • Clinical Application of Pharmacoepidemiology
  • Module 2: Adverse Drug Reactions and Safety Reports

  • Difference between Adverse Event and Adverse Drug Reaction
  • Classification of ADR
  • SAE Reporting
  • Side effects and medication errors
  • Module 3: Methodologies and Benefit assessment of medicines in Pharmacovigilance

  • Passive Reporting- Spontaneous reports and case series
  • Active surveillance
  • Targeted Clinical Investigations
  • Descriptive Studies
  • Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance

  • Argus
  • ArisG
  • MedWatch
  • MedRA
  • Module 5: Seriousness & Expectedness & Causality Assessment Criteria

  • Expectedness Assessment
  • Causality Assessment
  • Naranjo Algorithm
  • Hill’s Criteria
  • Module 6: Aggregate Safety Reports and Risk identification and assessment

  • Development Safety Update Report (DSUR)
  • Periodic Adverse Drug Experience Report (PADER)
  • Periodic Benefit Risk Evaluation Report (PBRER)
  • Periodic Safety Update Report (PSUR)
  • Module 7: Pharmacovigilance Regulatory effects and Medicines risk communication in Various Countries

  • CDSCO, India
  • FDA, USA
  • EMEA, Europe
  • MHRA, UK
  • TGA, Australia
  • Module 8: Pharmacovigilance Programme in India (PVPI)

  • Services of Indian Pharmacopoeia Commission (IPC)
  • Adverse drug reaction (ADR) reporting in India
  • Pharmacovigilance System Master File & capacity building
  • Recent developments and future perspectives
  • Module 9: Materiovigilance across the Globe

  • Materiovigilance Program Of India
  • Medical Device vigilance in US, FDA
  • Guidance for manufacturers on vigilance in UK, MHRA
  • Materiovigilance services across EU and non-EU countries
  • Module 10: Signal Detection and Data Mining

  • Data Sources for Signal Detection
  • Tools for signal detection
  • Data mining- statistical techniques
  • Data mining methodologies
  • Module 11: Pharmacovigilance of Herbal Drugs

  • Need of pharmacovigilance in herbals
  • Herbals concept of adverse effect
  • Pharmacovigilance of herbal medicines: Current state and future directions
  • Challenges in Herbal Drugs Pharmacovigilance
  • Module 12: Pharmacovigilance Compliance and Inspections

  • Good pharmacovigilance practices
  • Coordination of pharmacovigilance inspections
  • Guidelines on PV Inspections (NMRA)
  • Pharmacovigilance Audits & Regulatory Inspections and Common Findings
  • Module 13: Training on Argus, ArisGlobal, ABcube etc software platforms

  • Argus
  • ArisGlobal
  • ABcube
  • Module 14: Industry Based Case Studies


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

    Programme Duration

    The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).


    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. This programme is approved by Quality Council of India (QCI), Government of India.

    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 Post Graduate Diploma/Executive Diploma in Pharmacovigilance, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programmes material, self-assessment assignments would be provided by the Institute. 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 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.

    In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical like Novartis, Paraxel, Makrocare, Genpact, Biocon, Wipro, TCS, Abbott, Apcerlife Sciences, Jubilant Life Sciences, Biosys, Quantum Solutions, Wockhardt, WNS, GVK, Merck Group, Sun Pharmaceuticals Ltd., Siroclin Pharm, IQVIA, Glenmark, Cipla Ltd., Macleods, Rhyme Life Sciences, IPCA Laboratories, Flamingo Pharma, Alembic, Cognizant Technology, Johnson & Johnson, Spectrum Pharmaceuticals, Torrent Pharmaceuticals Ltd., Zydus Cadila, Unichem Laboratories, Reliance Life Sciences, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

    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 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.

    Post Graduate Diploma/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.

    Pharmacovigilance involves activities related to understanding assessment, detection and prevention of adverse effects or any other drug-related problems Pharmacovigilance is a continuous process accepted for safety evaluation accompanied by steps to improve safe usage of medicines. Some of the job profiles related to the pharmacovigilance : Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations,Drug Safety Specialist

    View Prospectus

    Programme Fee Details

    How to apply

    For further enquiries, write to or call us on: / 18001031071 (Toll Free) , Phone: +91 11 26512850

    Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

    Placement Testimonials

    All existing and old students and training participants are requested to write to our Corporate Resources division on 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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    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like