Nikita Gawand
Associate Director, Pharmacovigilance @SK Life Science, Inc.
Boston, MA, US
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MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Aug 2022 — Present
Associate Director, Pharmacovigilance @SK Life Science, Inc.
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EDUCATION
2001 — 2005
University of Mumbai
Bachelor of Pharmacy (BPharm)
2014 — 2016
Northeastern University
MS in Regulatory Affairs for Drugs, Biologics and Medical devices, 510K submission, Clinical protocol and ICF, SOP, NDA and IND submission in eCTD format, BLA
2006 — 2008
University of Mumbai
Master of pharmacy, Natural Products Chemistry and Pharmacognosy
SKILLS
U.s. Food and Drug Administration (Fda)Uv/VisGlpCrfGood Laboratory Practice (Glp)Medical DevicesPharmaceuticsIndProtocolTeam LeadershipHplcRegulatory SubmissionsCase ProcessingHipaaPharmaceutical IndustrySopFdaRegulatory Strategy DevelopmentClinical ProtocolsCalibrationRegulatory AffairsClinical Data ManagementAndaIcfNdaIch-GcpRegulatory ComplianceEdcPharmacologyBiotechnologyMedical TerminologyCecMicrosoft OfficeProject PlanningGood Clinical Practice (Gcp)IrbInternal AuditSae ReconciliationGmpRegulatory Documentation
ABOUT NIKITA GAWAND
Associate Director, Pharmacovigilance
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