PK Scientist Job at Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories, a leading multinational pharmaceutical company, is seeking a PK Scientist – Clinical Pharmacokinetics to join its team in Hyderabad. This role involves protocol preparation, BE study analysis, regulatory submissions, and collaboration with CROs to ensure high-quality pharmacokinetic research. If you have expertise in clinical pharmacokinetics, clinical research, GCP/GLP, and BA/BE studies, this is an excellent opportunity to advance your career in the pharmaceutical industry.
Job Posting: PK Scientist – Clinical Pharmacokinetics
About Dr. Reddy’s Laboratories
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.
Job Description for PK Scientist Job at Dr. Reddy’s Laboratories
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
Preparation and Review of Biostudy reports for specified markets
- Review the summary of pilot BE studies report towards the submission to regulatory affairs
- Review of report wrt clinical domain, eCTD review and submission to RA as per the required timeliness
- Leverage gap assessment
- Investigational product handling
BE results compilation for allocated projects
- Preparation of statistical analysis of the pilot and pivotal BE studies
Coordination with CROs
- To coordinate with the CRO’s/vendors for BE study follow up, progress and execution
Qualifications
- Post-graduation in Pharmacy
Additional Information for PK Scientist Job at Dr. Reddy’s Laboratories
- Clinical Pharmacokinetics, Clinical research, GCP/GLP, BA/BE
Keywords: Clinical Pharmacokinetics, PK Scientist, Dr. Reddy’s Laboratories, Hyderabad, Pharmacy, Clinical Research, GCP, GLP, BA, BE
