Position : Medical Reviewer

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
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
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