Senior Executive- Pharmacokinetics

Job Description:

Responsibilities

•  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 

Qualification & Experience

• M.Pharm
• Experience
• Tenure : 4-6 years