Devi Manjula
Associate Director at Gsk
Based in Bengaluru, India
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Seniority
Director
Department
Manufacturing & Production
Location
Bengaluru
Industry
Pharmaceutical Manufacturing
Company size
92K
Contact information
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d•••••••@gsk.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Devi Manjula
MBBS, MD Pharmacology with 20+ yrs of clinical research experience as Head Clinical operations, Principal Investigator in healthy volunteer BA/BE, Phase I to PK/PD studies with Biosimilars (Biologics), skin blanching, and QTc validation studies. I have also handled patient-based Biosimilar(in therapeutic areas of Oncology, Neurology, Cardiology, Gastroenterology, and Orthopaedics) and phase studies as Medical Monitor. I am responsible for providing efficient technical and operational leadership for clinical development programs, overall team development, people management, audit preparedness, project management, and improvement of existing systems and processes. I have successfully handled audits from WHO, USFDA, CDSCO, ANVISA, and TMMDA regulatory agencies for BA/BE studies.
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