Pharmacokinetic Scientist in Sun Pharmaceutical Industries Limited

Job Posted on Feb 17, 2023

Recruiter Type:Company
Company Name:Sun Pharmaceutical Industries Limited
Address:R&D Baroda
Contact Person:HR
Required in:R&D
Job Department(s):Research
Job Title:Pharmacokinetic Scientist
Job Details:Pharmacokinetic Scientist
Experience: 5 - 10 years in Pharma industry

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 concurrance or advice.
7. Having in-depth understanding of in-vitro parameters and indentification of critical variables impacting the in-vivo release. Perform IVIVC, simulation and Pharmacokinetic modelling to improve BE success.

Send in your resume to :
Regulatory Exposure:Not Required
Experience:5-10 Years
Last Date:22/02/2023

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