PK Scientist - Clinical Pharmacokinetics

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas. The company produces over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.

1. Preparation of Synopsis -All geographies

(i) Prepare synopsis for the preparation of protocols for BE study

(ii) Review and submission of the BENOC protocols for DCGI submission

(iii) To provide CPK inputs for preapex products

1. Preparation and Review of Biostudy reports for specified markets

1. Review the summary of pilot BE studies report towards the submission to regulatory affairs 
2. Review of report wrt clinical domain, eCTD review and submission to RA as per the required timeliness  
3. Leverage gap assessment 

3. Investigational product handling

To coordinate and arrange for the IPs from the PDTs and ensure shipments to respective CROs for the conduction of pilot and pivotal BE studies IN ORDER TO Ensure the availability of IPs before the initiation of the BE study

1. BE results compilation for allocated projects

i)Preparation of statistical analysis of the pilot and pivotal BE studies.

1. Coordination with CROs

To coordinate with the CRO's/vendors  for BE study follow up, progress and execution.  

Post-graduation in Pharmacy

Clinical Pharmacokinetics, Clinical research, GCP/GLP, BA/BE