Company: Sun Pharmaceutical Inds Ltd, Baroda
Post: Manager - Pharmacokinetics
Qualification: M.Pharm
Experience: 7-10 years
Job Description :
1. Literature search and study designing of Bioavailability and Bioequivalence studies(BA/BE) of oral & non-oral products towards different regulatory submissions.
2. Review of BA/BE study protocol and provide Pharmacokinetic (PK) & clinical inputs.
3. Develop a protocol for patient-based BA/BE studies for complex generics.
4. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE, food effect & Phase 1 PK studies, using Phoenix Software.
5. Coordinate with CROs in India and outside India for the finalization of the pilot and pivotal bio-study protocol for regulatory application.
6. Handling of regulatory queries by providing a sound scientific response.
Send in your resume to: rosemary.varghese@sunpharma.com
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