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Post Graduate Diploma in Pharmacovigilance is a comprehensive one-year programme. The course is designed to offer candidates practically important information about the industry type, working modalities, techniques of quality control, and drug development, among others. The goal of the Post Graduate Diploma is to familiarise the participant with the updated theoretical and practical aspects of Pharmacovigilance.
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Candidates must have completed a bachelor's degree in any relevant field from an accredited university to apply for the PG Diploma in Pharmacovigilance programme. Some universities admit only those candidates who have prior experience in the field. The top colleges that offer PGD Pharmacovigilance are IGMPI India and JIS University.
Students can choose careers such as Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, and Drug Safety Specialist. Top Companies that hire graduates after PG Pharmacovigilance are Novartis, Parexel, Makrocare, Genpact, Biocon, Wipro, TCS, Larsen and Toubro, Wipro, UnitedBioSource, and Vial.
Particulars | Values |
---|---|
Course Name | Post Graduate Diploma in Pharmacovigilance |
Course Duration | 1 year |
Eligibility Criteria | Bachelor’s degree in any relevant discipline |
Admission Process | Merit-Based |
Average Salary | Rs. 4.1 Lakhs |
Average Fees | Rs. 75,000 |
Entrance Exams | Some institutions may conduct entrance exams |
Top Companies | Accenture, Cognizant Technologies, ICON, Paraexel, TCS, Larsen and Toubro, Wipro, UnitedBioSource, Vial |
Job Positions | Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, Drug Safety Specialist |
For admission to the PG Diploma in Pharmacovigilance, different colleges and universities have different course eligibility criteria. Some universities accept students based on their scores in graduation, while others require students to take entrance exams.
Eligibility Criteria | Details |
---|---|
Educational Qualification | Candidates must hold a bachelor’s degree in a relevant field |
Minimum Marks | Typically, a minimum of 50% aggregate marks in the qualifying degree is required. |
Entrance Exam | Admissions are mostly merit-based, but some institutes may conduct personal interviews or screening tests. |
PGD Pharmacovigilance colleges have different prerequisites for admission. While most colleges offer direct admission to this course, some colleges might ask the candidate to appear for a university-specific entrance exam. Candidates are advised to carefully follow the admission procedure. The admission process for the PG Diploma in Pharmacovigilance is as follows:
Step 1- The candidate must go through the eligibility criteria and the instructions provided by the respective colleges before applying.
Step 2- Candidates are required to fill out the registration form from the aspired college’s website and upload the necessary documents.
Step 3- After registration, the candidate should appear for the entrance examination, if advised by the preferred college. If the college offers direct admission based on graduation scores, the candidate can move on to the final step.
Step 4- The final step is to pay the required fees to secure your spot.
The entire diploma is divided into 14 Modules, which are designed to provide relevant skills and knowledge to the enrolled students. The course ensures that the student understands the main epidemiological and statistical principles, concepts, and tools that are used in pharmacovigilance practices and research.
Module 1 | |
Basics of Pharmacology | Phases of Clinical Trials |
Clinical Application of Pharmacoepidemiology | Pharmacovigilance methods |
The Clinical Research Industry | - |
Module 2 | |
Difference between Adverse Event and Adverse Drug Reaction | Classification of ADR |
SAE Reporting | Side effects and medication errors |
Module 3 | |
Passive Reporting- Spontaneous reports and case series | Active surveillance |
Targeted Clinical Investigations | Descriptive Studies |
Module 4 | |
Argus | MedRA |
WHODD | MedWatch |
ArisG | - |
Module 5 | |
Expectedness Assessment | Causality Assessment |
Naranjo Algorithm | Hill’s Criteria |
Module 6 | |
Development Safety Update Report (DSUR) | Periodic Adverse Drug Experience Report (PADER) |
Periodic Benefit Risk Evaluation Report (PBRER) | Periodic Safety Update Report (PSUR) |
Module 7 | |
CDSCO, India | FDA, USA |
EMEA, Europe | MHRA, UK |
TGA, Australia | - |
Module 8 | |
Services of the 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 Program Of India | Medical Device Vigilance in US, FDA |
Guidance for manufacturers on vigilance in the UK, MHRA | Materiovigilance services across EU and non-EU countries |
Module 10 | |
Data Sources for Signal Detection | Tools for signal detection |
Data mining- statistical techniques | Data mining methodologies |
Module 11 | |
Need of pharmacovigilance in herbals | Herbal concept of adverse effect |
Pharmacovigilance of herbal medicines: Current state and future directions | Challenges in Herbal Drugs Pharmacovigilance |
Module 12 | |
Good pharmacovigilance practices | Coordination of pharmacovigilance inspections |
Guidelines on PV Inspections (NMRA) | Pharmacovigilance Audits & Regulatory Inspections and Common Findings |
Module 13 | |
Argus | ArisGlobal |
ABcube | - |
Module 14 | |
Industry-based case studies | - |
The PG Diploma in Pharmacovigilance fees vary from college to college. Government colleges' fees are lower, while Private universities charge a high amount. The average fee for this diploma is Rs. 75,000.
The course fees for Post Graduate Diploma (PGD) in Pharmacovigilance can vary significantly depending on the institute, course duration, mode of delivery (online/offline), and additional certifications included.
There is a lot of scope after the completion of the Postgraduate Diploma in Pharmacovigilance course. Students can get job roles such as Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, and Drug Safety Specialist. Further education is also an option for students. Students can go for a master's degree in Public Health, Pharmaceutical Sciences, or Clinical Research.
The Indian pharmaceutical industry is a booming one, with more than 8000 licensed drug manufacturers. In India, pharmacovigilance professionals are in great demand. Besides the Indian market, the U.S. market has an equally high demand for such professionals. Therefore, Pharmacovigilance professionals are desired by both domestic and international employers.
Pharmacovigilance Expert: Pharmacovigilance Experts perform a crucial role in clinical trials by collecting and analysing useful data and ultimately aiding in the availability of safe medicines and treatments for patients. They collect, evaluate, and analyse adverse event data to ensure that medications are safe and effective for public use.
Drug Safety Associate: Drug Safety Associates play an important role in determining whether drugs manufactured are safe or not by analysing clinical trial reports. Their work supports regulatory decisions and contributes to the safe use of medicines.
Clinical Operation Manager: Clinical Operation Managers oversee and guide the operations of a medical or healthcare facility. They determine the tasks and objectives and keep track of all the activities of the clinic. They manage timelines, budgets, compliance and ensure that clinical trials run smoothly and efficiently.
Drug Safety Specialist: A Drug Safety Specialist ensures that drugs are manufactured, tested, and marketed by regulatory guidelines and that adverse events or product quality issues are reported to the relevant regulatory authorities. They monitor adverse events, prepare safety reports, and liaise with regulatory bodies to maintain public health standards.
Post Graduate Diploma in Pharmacovigilance is a comprehensive programme offering candidates knowledge and practically important information about the industry type, working modalities, techniques of quality control, and drug development, among others.
Knowing all theoretical and practical facts about post-marketing surveillance makes the candidate comfortable and confident when working in the industry. Moreover, the field of pharmacovigilance is a rapidly growing industry. Careers in this field can lead to director or managerial positions with decent salaries.
A PGD in Pharmacovigilance generally prepares candidates for entry-level roles with salaries ranging from Rs. 4.2 to 7.1 LPA. With experience and strategic career moves, mid-level positions can reach Rs. 10 to 15 LPA, senior managerial roles Rs. 12 to 20+ LPA, and leadership/director roles can surpass Rs. 25 LPA in top organisations or metro cities such as Gurugram, Mumbai, or Bengaluru.
Job Profile | Average Salary |
---|---|
Pharmacovigilance Expert | Rs. 7.1 LPA |
Drug Safety Associate | Rs. 4.2 LPA |
Clinical Operations | Rs. 6.4 LPA |
Drug Safety Specialist | Rs. 6.0 LPA |
Source: Ambition Box
As the demand for drug safety professionals continues to rise, several top institutes in India have introduced specialised Post Graduate Diploma (PGD) courses in Pharmacovigilance. These programmes are designed to equip students with practical knowledge of adverse drug reaction monitoring, regulatory frameworks, clinical research, and risk management.
Name of the college | Fees |
---|---|
Rs. 1.10 Lakhs | |
Rs. 75,000 | |
Rs. 1.46 Lakhs | |
Rs. 1.57 Lakhs | |
Department of Technology, Savitribai Phule Pune University, Pune | - |
ICRI India | - |
AIICR (Advanced International Institute of Clinical Research), Jaipur | - |
Post Graduate Diploma in Pharmacovigilance is a comprehensive one-year programme. The goal of the Post Graduate Diploma is to familiarise the participant with the updated theoretical and practical aspects of Pharmacovigilance. Students can get job roles such as Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, and Drug Safety Specialist at top companies after the completion of the course.
Frequently Asked Questions (FAQs)
There is a lot of scope after the completion of Post Graduation Diploma in Pharmacovigilance course. Students can get any related job roles and also opt for further education is also an option for students.
Students can get job roles like Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, and Drug Safety Specialist.
Students can go for a master's degree in Public Health, Pharmaceutical Sciences, or Clinical Research.
The duration of PGD Pharmacovigilance is one year. However, one can pursue an executive diploma in the field which is for 6 months.
Top recruiters include Novartis, Parexel, Makrocare, Genpact, Biocon, Wipro, TCS, Abbott, Apcer Life Sciences, Jubilant Life Sciences, Biosys, Quantum Solutions, Wockhardt, WNS, GVK, Merck Group, Sun Pharmaceuticals Ltd.
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