Careers
:
These team members will be recruited at FHS PV unit for managing Medical Review of ICSRs and aggregate reports. All these employees would be having expertise and experience in medical review of cases processed in ARISg and/ or ARGUS with reputed PV firms.
Experience : 3-5 years in medical review of ICSR and aggregate reports
Educational background: MBBS
Specific Technical responsibilities |
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Triaging of case reports and literature articles |
Medical Review and approval of Individual Case Reports |
Medical Review of Aggregate reports |
Review of literature articles/hits for relevance |
Medical Review of Signal Reports |
Review of Health Hazard Asseessment |
Review of risk management plans |
Review of Quality investigation reports |
Review of any pharmacovigilance documents after relevant training as required |
General Technical responsibilities |
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Quality feedback to case processing and literature teams |
Review of question logs |
Provide inputs to preparation of SOPs and other guidance documents |
Knowledge sharing and training of drug safety and risk management team |
Review and feedback of MEDRA updates |