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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 the Pharmacovigilance.
Candidates must have completed a bachelor's degree in any relevant field from an accredited university to apply for 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, Institute of Good Manufacturing Practices, and JIS University.
Students can opt for 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, Vial.
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. 3 Lakhs |
Average Fees | Rs. 1 Lakhs |
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.
A student must have a bachelor's degree.
Graduates from B.tech/ B.Sc. in Microbiology/ Life Sciences/ B.Sc in Botany/ B.Sc in Zoology/ Food Science/ BE/ B.Pharma/ MBBS/ Food Technology/ BDS/ BHMS/ BUMS/ BAMS or any other discipline are also eligible.
Graduates, diploma holders, and working professionals are also eligible to pursue the diploma.
Some universities also conduct entrance exams that are to be cleared to be eligible for the diploma course.
Some universities may want the candidates to have work experience.
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:
The candidate must go through the eligibility criteria and the instructions provided by the respective colleges before applying.
Candidates are required to fill out the registration form from the aspired college’s website and upload the necessary documents.
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.
The final step is to pay the required fees to secure your spot.
PGD Pharmacovigilance requires the candidates to have certain skills to perform well academically and professionally in their careers. To pursue this diploma, one must be skilled in certain areas so that the learning could become easier. Some of the skills that one must have are mentioned below:
Analytical Skills
Quantitative Aptitude
Information Management Skills
Attention to detail
Problem-Solving
Regulatory and Ethical Knowledge
Communication Skills
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 varies from college to college. Government colleges are usually inexpensive while Private universities offer the diploma at a high fee. The average fee for this diploma is Rs. 1 Lakh.
There is a lot of scope after the completion of the Postgraduate Diploma in Pharmacovigilance course. Students can get job roles like 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 the patients.
Drug Safety Associate: Drug Safety Associates play an important role in determining whether drugs manufactured are safe or not by analysing clinical trial reports.
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.
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.
Accenture
Cognizant Technologies
ICON
Parexel
TCS
Larsen and Toubro
Wipro
UnitedBioSource
Vial
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.
Salary after PGD Pharmacovigilance depends upon the job profile, employer as well as the experience of the candidate. The average salary for entry-level positions is Rs. 3 LPA while experienced professionals may earn an average salary of Rs. 10 LPA.
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
PG Diploma in PGD Pharmacovigilance programmes is available at several Indian universities. Some of India's top institutions and institutes that offer PGD PGD Pharmacovigilance include:
Name of the college | Fees |
---|---|
Rs. 1,10,000 | |
Rs. 75,000 | |
Rs. 1,46,500 |
PG Diploma in PGD Pharmacovigilance courses are offered by several private Indian institutes. Private institutes are slightly more expensive than government institutes. Mentioned below are the top colleges offering the PG Diploma course along with their respective fees:
Name of the college | Fees |
---|---|
JIS University | Rs. 75,000 |
Adesh University | Rs. 1,46,500 |
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 the Pharmacovigilance. Students can get job roles like Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, and Drug Safety Specialist at top companies after the completion of this diploma.
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.
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 go for a master's degree in Public Health, Pharmaceutical Sciences, or Clinical Research.
Students can get job roles like Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations, and Drug Safety Specialist.
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