Research Scientist - Pharmacokinetics

Sr. No.

- Roles and Responsibilities

1

Preparation of study synopsis for BA/BE studies. Coordination with CRO for feasibility and budget.

2

Thorough understanding in different regulatory guidance and clinical pharmacokinetics

3

Provide technical input during protocol development and regulatory correspondence.

4

Coordination with cross functional teams and CROs for BA/BE studies and BENOC/TL application

5

Ensure execution of pilot and pivotal bioequivalence studies in compliance with study protocol. 

6

Monitoring of Clinical studies in compliance with GCP, GLP and applicable regulatory requirements. Preparation of Monitoring reports.

7

PK data interpretation

8

Review of Study report

9

Post submission regulatory query response

10

Proficiency in Phoenix & MS Office will be an added advantage