Senior Executive- Pharmacokinetics

About the role

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

What you'll do

• 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

What you need

• Regulatory affairs
• CRO
• BA or M.Pharm