Sun Pharmaceutical Industries Ltd Job Vacancy For R&D Department
Sun Pharmaceutical Industries Ltd Job Vacancy For R&D Department |
●Opening For:- Pharmacokinetic Scientist
●Experience: 5-10 years in Pharma industry
●Location:- Baroda
●Job Description:-
1. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products(injectable, Semisolids, TDS etc.) towards different regulatory submission.
2. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols
3. Developing protocol for patient based PK end point & also for PD/Clinical end point BE studies for complex generics.
4. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.
5. Coordinate with the CRO in India and outside India for finalizing biostudy pilot and pivotal study protocol for DCGI BE application.
6. Preparation of pharmacokinetic queries response, scientific justification for study design/ protocol/ results towards various regulatory agencies for their concurrence or advice.
7. Having in-depth understanding of in-vitro parameters and identification of critical variables impacting the in-vivo release. Perform IVIVC, simulation and Pharmacokinetic modelling to improve BE success.
●Send in your resume to: HR.Tandalja@sunpharma.com
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