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| What we do |
| QSI is specializing in providing services to global pharmaceutical companies... |
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| Our strengths |
| QSI is an organization specializing exclusively in Drug Safety. Our primary strength is Safety Operations... |
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Our team consisting of highly qualified physicians, healthcare professionals and scientific personnel, specializes in drug safety/pharmacovigilance operations. Dramatic growth is reflected in our numbers growing more than 70 times since 2004.
We have several Operations teams. Each team is dedicated to, and works for a designated client in a ‘ring-fenced’ manner and typically ranges from about 7-10 to 20-25 healthcare professionals and life scientists. These scientists work under a Project/Team Lead and report to the Head of the Operations.
The team of physicians, under a Team Lead, also reports through operations. Their areas of specialization include:
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Anesthesiology |
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Obstetrics and Gynecology |
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ENT |
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Ophthalmology |
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Forensic Medicine |
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Pathology |
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Dermatology |
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Pediatrics |
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Geriatrics |
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Pharmacology |
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Internal medicine |
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Psychiatry |
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Our healthcare professionals come from diverse backgrounds and have professional degrees in the following areas:
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Pharmacy |
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Dentistry |
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Experimental Medicine |
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In addition we have a large team of scientists with a background in life-sciences, usually with at least a Masters-level or Ph.D. degree, in one of the following fields:
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Biochemistry |
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Microbiology |
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Biotechnology |
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Food and Nutrition |
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Biophysics |
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Forensic Sciences |
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Cell/Molecular Biology |
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Bioinformatics |
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Human Genomics |
QSI has been working in the Drug Safety area for the last eight years; the average experience level of personnel in operation team is about three years. The senior-most batch of scientists has been with the organization since inception for this entire eight-year duration. The average age of the QSI scientist is 28 years. All PV scientists, other than the physicians, have a life sciences background and about 60% of them are healthcare professionals (pharmacists, dentists etc.)
The QSI team is perfectly familiar with:
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General PV principles |
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ICH guidelines |
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Volume 9A requirements |
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FDA rules and regulations |
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The QSI team is well versed in MedDRA, various drug dictionaries, submission criteria, CIOMS and global regulatory framework requirements.
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