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- Preparation of Medical and safety related SOPs
- Coordination with the Sponsor, Investigative site and Project Management team for any Medical or Safety related issues
- 24x7 Serous Adverse Event reporting services in compliance with the Indian regulations and the Sponsors’ SOPs including
preparation of SAE case narratives
- Receiving, processing, archiving of Serious adverse event information including CIOMS reports
- Set up and maintenance of a safety database
- Medical support for SAE reconciliation
- Medical review of CRFs
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