PK Specialist

Company Description

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

On site and Remote Monitoring of BA/BE studies conducted in various CROs across India, To verify the conduct of study in accordance with IEC/IRB approved protocol and applicable regulatory requirements. Adherence to GCP/GLP and regulatory requirements. Preparation of Monitoring Plan, Pre-monitoring visit checklists, Monitoring Checklists, Monitoring Observations, CAPA and Monitoring visit Reports & Clinical Updates Review etc. Maintaining monitoring dashboard and tracker of CRO with updated audit history along with latest EIR reports

Qualifications

Post-graduation in Pharmacy having atleast 8 - 10years of experience, Clinical study monitoring activities, Clinical research operations of BA/BE studies.

Additional Information

Open for travel as BE studies will be executed across India