Drug Safety & Medical Review for Physicians : Medical professionals play an important role in the global pharmacovigilance system. They require substantial understanding and expertise in the field of drug and device safety which will successfully contribute to this area through early recognition, management, and reporting of the drug and device safety issues. It is important that medical professionals should be formally trained in the pharmacovigilance. They should possess a combination of training and skills in this area.
Pharma Research program covers the entire spectrum of drug safety physician / medical reviewer role.
Drug Safety & Medical Review for Physicians : Pharmacovigilance has grown significantly in recent years and its importance in the healthcare system has been recognized worldwide. There are considerable issues which need to be addressed to ensure the safety of medicines and medical devices.
Medical professionals play an important role in the global pharmacovigilance system. They require substantial understanding and expertise in the field of drug and device safety which will successfully contribute to this area through early recognition, management, and reporting of the drug and device safety issues. It is important that medical professionals should be formally trained in the pharmacovigilance. They should possess a combination of training and skills in this area.
Drug Safety & Medical Review for Physicians : 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 and off shoring for every pharmaceutical and medical device company. Large numbers of global drug and device companies have starting off shoring their pharmacovigilance activities to the markets like India. In a typical pharmacovigilance department or specialized pharmacovigilance company, there are several entry level positions for medical doctors, viz. Drug Safety Physician, Medical Reviewer, and Safety
Scientist, and this leads to higher positions over the years at fast pace.
Career in Medical Science
Substantial career growth
Attractive salaries
5 days a week job
International training and job opportunities
Fixed holidays and annual vacations
To learn the applicable clinical research guidelines, personnel & stakeholders responsibilities, clinical trial study processes, Clinical Data management, Pharmacovigilance etc.
Pharma Research Program covers the entire spectrum of Drug Safety Physician / Medical Reviewer Role. Following
are the key topics
1. Introduction to Pharmacovigilance
2. Global Pharmacovigilance Regulations
3. Reportability Criteria & Case reports
4. Safety reporting and Processing ICSR Medical Evaluation of ICSR
5. Aggregate Report Writing
6. Signal Detection & Risk Management
– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, MD, MS, DNB , BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
You can also view our FAQs page for further queries.
Student 3200
Length: 4 weeks
Timings: Self Paced
Language: English
Effort: 55 hrs. approx
Skill Level: All
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