Job Description

Basic understanding of Clinical pharmacology, pharmacokinetics and toxicological aspects Review of literature and preparation of Biopharmaceutics review, Dissolution studies , Biowaiver/Bio strategy Basic understanding of bioequivalence studies for various regulatory agencies Review of study specific documents for BE studies (like study protocol, ICF,CRF, CSR, TMF) Monitoring & audit of clinical phases of Biostudies and Quality management system Co-ordination with CROs for execution of Pilot and Pivotal bioequivalence studies. Co-ordination with internal departments for BE NOC/TL documents and project contracts/invoices. Management, receipt, logistics and shipment of study IMPs to CRO’s Submission of finalized BE reports to regulatory department for submission and handling of regulatory queries related to module 5. Basic understanding of GCP Guideline and Clinical trials, NDCT Rule etc