Bhaskar G.
Senior Central Review Manager - Clinical Operations at PPD, Part of ThermoFisher Scientific
- Role
- Senior Central Review Manager - Clinical Operations at Ppd
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Bhaskar G.
Rich hands on experience in Clinical operations, Quality Assurance, Regulatory Affairs and Pharmaceutical Industry.• Excellent knowledge with Clinical domain experience from the start to end processing of clinical trials.• Expertise in co-ordination, preparation and review of documents/ packages for regulatory submissions, which includes Drug Controller General of India [DCG(I)] and Central Bureau of Narcotics [CBN] submissions.• Excellent skills in Regulatory/ EC Submission dossier, Site Selection, Initiation, Monitoring, Close- out visits, SAE Reporting, Inspections help,(eCRF, EDC) Data Query Generation and Resolutions.
Experience
Senior Central Review Manager - Clinical Operations
Jan 2022 — Present · Hyderabad, IN
Education
Smt.C.H.M. COLLEGE
PG DIPLOMA, CLINICAL RESEARCH
2007 — 2008
D.G. RUPAREL COLLEGE
BSC, CHEMISTRY
2003 — 2006
B.P.P.M High school
SSC
2000 — 2001
A E S Jr College
SCIENCE, HSC (SCIENCE)
2002 — 2003
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