- Introduction
- Introduction to pharmacovigilance terminologies part 2
- Course methodology
- Roles and Responsibilities
- Causality Assessment
Pharmacovigilance officer in-charge is major role in India. When you are taking up a a job or attending a interview it is important to know about the role. Company starting pharma production can also use this presentation to understand the multiple implications. The role involves monitoring multiple location, tracking of incoming reports, hands on experience in setting up of operational procedures, creation of training timing, creation of audit schedules,management of report and signal detections
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Ph.D in Toxicology, designed PSMF software's for Indian Pharma firms as per MAH Guidelines, android solutions and automatic audit systems for pharmaceutical firms. Have created SOP for pharmacovigilance process, created audit procedures, ADR reporting, processing, data collection and review, created training material for all modules of MAH guidelines for Indian PSMF file management. Have work experience of 20 years in senior management, clinical research, audit and data management. have conducted several senior management pharmacovigilance review and risk management plans for various products.