Vipasha Bhatt
Bis 2020, Clinical Research Associate, Alembic Pharmaceuticals Limited, India
Abschluss: Bachelor, Gujarat Technological University
Leonberg, Deutschland
Werdegang
Berufserfahrung von Vipasha Bhatt
* Preparation, implementation, follow-up of Site initiation and monitoring visits as part of the clinical study. * Assessing the quality and integrity of site practices. * Source data verification and writing monitoring reports. * Projects: GeparDouze, GeparPippa, Sascia, Destiny, Olympia. * Software: Medcodes, Marvin, Raves/ Medidata.
2 Jahre, Juni 2018 - Mai 2020
Clinical Research Associate
Alembic Pharmaceuticals Limited, India
*Preparation of clinical summary and study reports as per regulatory requirements. *Performing study/screening activities of volunteers, ICF presentation, supervising study activities, check-in and check- out of subjects, dosing activity, segregation, preparation of Trial Mater File and verification of study documents for completeness and correctness.
2 Jahre und 1 Monat, Juni 2016 - Juni 2018
Junior Research Associate
Veeda Clinical Research
*Report preparation (Pivotal-Pilot Study reports, Method validation Report, Amendments, Canadian and WHO reports) as per the regulatory bodies like USFDA, EU, ANVISA, DCGI *Production of high-quality subsequent documents like ECTD as per Regulatory submission and compiled regulatory documents *Data Interpretation in clear and accurate manner with WATSON LIMS Software
Ausbildung von Vipasha Bhatt
4 Jahre, Juni 2012 - Mai 2016
Pharmacy
Gujarat Technological University
Also did a certificate course in Regulatory Affairs
Sprachen
Deutsch
Gut
Englisch
Fließend
Hindi
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