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sun pharma industries
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Senior Executive- Pharmacokinetics

Senior Executive- Pharmacokinetics

sun pharma industries

4 - 6 years

|

10 - 11 Lacs

Posted:13 hours ago| Platform:

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Skills Required

pilot cro literature statistical analysis senior executive pharma pharmacokinetics regulatory affairs inventory

Work Mode

Work from Office

Job Type

Full Time

Job Description

Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission.

Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols

Coordinate with the CRO in India and outside India for finalizing biostudy pilot and pivotal study protocol for DCGI BE application.

Develop protocol for patient based BA/BE studies & PD end point study for complex generics.

Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.

Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission.

Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols

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