Karunakar Reddy
R & D Physician, Government Affairs, Medical Affairs & Market Access
- Role
- Head, Government Affairs at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Karunakar Reddy
33 years of working experience in Research and Development, Government Affairs, Market Access, Medical Affairs, Global Clinical Safety and Pharmacovigilence, Global Clinical Operations (Study Management), and Medicine Development in various therapeutic areas.Accountable and provide Medical Governance across the project to ensure scientific integrity & engagement and the overall safety of the study subjects.Provide clinical leadership of the disease area, lead disease area education as required, build and maintain knowledge of the field and competitive intelligence.Drive key organizational process improvement initiatives from concept to delivery resulting in identifying new investigators and sites for increased productivity.Develop strategies to work with investigators/coordinators for site partnerships and persuade the inactive site investigators to revitalize their sites to enroll. Innovative in process as a point of contact for sites questions relating to the study.Partner with various teams to increase the reliability and speed of recruitment in conducting clinical trials in developing countries for significant cost savings.Specialties: Government Affairs, Medical Affairs, Clinical Development, Global Clinical Operations, Study Management, Safety & Pharmacovigilence.
Experience
Head, Government Affairs
Oct 2021 — Present
Nurturing and deepening access at various central & state government agencies like NPPA, CDSCO (India FDA), State regulatory (DCA) agencies and FSSAI (central and state level).Some key areas include collaborating with state DCAs to control counterfeit/copycat labels issues, resolutions for Not of Standard Quality (NSQ) notices and with the NPPA on Trade Margin Realization, One-time settlements & PAP program implications.Led the team for discussions with CDSCO, visiting North Eastern Region of India & KOLs to launch a new molecule in Oncology TA, India 3d country in the world (after China & USA).Pivotal role in upscaling networking with bureaucrats, politicians, and the medical fraternity.A COVID warrior with Helping Hands initiative for the company, across regions.
Education
Shivaji University
M.B;B.S.
1984 — 1989
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