Hyderabad / Secunderabad; Clinical Pharmacology And Pharmacokinetics; B.Pharm, M.Pharm; Dr. Reddys Laboratories Ltd..

Experience: 1 - 6 Years

Location: Hyderabad / Secunderabad
Desired Candidate Profile

1)Pharmacokinetic Investigator for BA/BE studies.
2)Pharmacokinetic inputs in protocols and reports of BA/BE studies, Phase I-IV studies with PK end points.
3)Review of clinical study reports.
4)Carry out BA-BE (Bio availability- Bio equivalence) studies.

Job Description
•Identify the advancements in the field of clinical pharmacology and pharmacokinetics
•Keep abreast with the new technologies in this field.
•Carry out BA-BE (Bio availability- Bio equivalence) studies.
•Provide support to the various PDTs.
•Prepare synaptic protocol and submit it to CROs (Clinical Research Organisation).
•Review the Draft protocols and send it back to CROs with modifications, if any.
•Get IRB approval for the new product.
•Get BENOC (Bioequivalence No Objection Certificate) from DCGA.
•Do statistical and pharmacokinetic analysis of the pilot study report.
•Respond timely and adequately to FDA deficiencies and prepare justification reports.
•Be a part of BAT and discuss the development of the new product and approve/reject it for further studies.
•Review the reports of pivotal tests and submit them to RA.
•Coordinate with the CROs.
•Carry out appropriate experimentation and documentation

send resumes to: talent@drreddys.com