Regulatory bodies such as the USFDA and EMEA are intensifying safety regulations,
thereby boosting the adoption rates of pharmacovigilance systems by pharmaceutical
companies. Several countries, including India are in the process of implementing
stringent regulations for adoption of pharmacovigilance. There is significant potential
for outsourcing/off shoring for mid-sized companies as well. Large number of global
drug companies have starting off shoring their pharmacovigilance activities to the
markets like India. In a typical pharmacovigilance department or specialised pharmacovigilance
company, there are several positions. Pharmacovigilance offers excellent growth
prospects. Some of the positions are Drug Safety Associate; Drug Safe Scientist;
Aggregate Report Scientist; Team Leaders.
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: Online/Distance Learning
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: 6 Months
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: MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharms, Graduate/Post Graduate Degree
in Life Sciences, Mathematics, Pharmacology, Pharmacy, Medical Laboratory, Nursing,
Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical
companies, CROs and Hospitals.
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: Printed Training Modules; Online e-learning System
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: Online MCQs
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: Certificate would be awarded upon successful completion of the program. Program
is Certified & Accredited by the Pharmaceutical Society of India.
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: Accreditation would be awarded upon successful completion of the program. Program
is Certified & Accredited by the ACCRE US & Swiss Society of Pharmaceutical Medicine.
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: Placement support would be provided to the successful candidates. CVs of successful
candidates would be forwarded to CROs Hospitals and Pharmaceutical companies and,
Interviews would be organized.
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: Fee Payable by Cash, Cheque/Bank draft in the name of “TENET HEALTH EDUTECH PVT
LTD.” payable at Delhi. Fee can also be deposited in company bank account.
We also accept Credit/Debit Cards.
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: Through Debit/Credit cards using Paypal or wire payment through banks
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: The program would cover
- Introduction to Clinical Research & Phases in Clinical Research
- Principles of Good Clinical Practices - ICH GCP
- General Overview of Pharmacovigilance
- Medical Dictionary for Drug Regulatory Activities MedDRA
- Regulatory Aspects in Pharmacovigilance
- Diagnosis And Management of Adverse Drug Reactions
- Medical Evaluation of Adverse Events
- Quality System in Pharmacovigilance
- Expedited Reporting Requirements
- Periodic Safety Update Reports (PSUR,s) For Marketed Drugs (ICH E2C)
- Pharmacovigilance Database And Signal Detection Tools
- Risk Assessment, Evaluation And Management
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- Candidate should able to understand the basic concepts, importance of Pharmacovigilance
and Global Pharmacovigilance regulations.
- Practical aspects of important Pharmacovigilance activities as per the global standards
like medical evaluation, casualty assessment, expectedness assessment, case narratives,
MedDRA, case processing preparation of safety report etc.
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