Looking for competent candidate for Clinical Research BA/BE-R&D (Executive). Prior Candidates having experience in conducting and Monitoring Bioequivalence studies and having working with CRO. Basic understanding of Clinical pharmacology, pharmacokinetics and toxicological aspects. Review of literature and preparation of Bio pharmaceutics review, Dissolution studies, Biowaiver/Bio strategy notes. Basic understanding of bioequivalence studies for various regulatory agencies. Review of study specific documents for BE studies (like study protocol, ICF & CRF). Monitoring & audit of clinical phases of Bio studies and Quality management system. Co-ordination with CRO’s for ion of Pilot and Pivotal bioequivalence studies. Submission of finalized BE reports to regulatory department for submission and handling of regulatory queries related to module 5. And Basic understanding of GCP Guidelines and Clinical trials.
MPharm/MSc with 4-6 Years of similar experience would be a right fit for this position which is based at Bangalore. Interested may please get in touch with us:
email@example.com & firstname.lastname@example.org