Vaibhavi Patel
Clinical, Pharmacovigilance and Medical Quality Assurance
- Role
- Manager, Clinical Program Quality-oncology at Takeda
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Vaibhavi Patel
Healthcare and project management professional with more than 2 years of experience in Pharmaceutical industry with the vast knowledge of Drugs, Biologics and Medical devices in Biotechnology, pharmaceutical and Clinical research organization (CRO).I have a strong background in pharmaceutical science with the experience in clinical research and Quality assurance with the thorough knowledge of ICH, GCP, FDA, MHRA regulatory guidelines to market the drug in different countries of the world. I also have a fundamental knowledge of project management skills which I would like to implement with my experience in healthcare research makes me highly qualified to work in the pharmaceuticals with top positions.Technical skills/ Knowledge areas• Clinical research/Clinical pharmacology• Clinical data interpretation using statistical software. e.g. WinNonlin• PK-PD modelling • Quality assurance/ FDA-GCP, GLP guidelines• Analytical & Bioanalytical/ Instrument handling• Project management- Scope/Schedule/Risk management• Clinical trials monitoring • Clinical study protocol, ICF, IB preparation
Experience
Manager, Clinical Program Quality-oncology
Oct 2024 — Present
Education
Institute of Pharmacy, Nirma University
Master's Degree, Pharmaceutical analysis and Quality assurance
2013 — 2015
Northeastern University
Master of Science - MS, Project Management (Clinical)
2017 — 2019
Institute of Pharmacy, Nirma University
Bechlors of Pharmacy, Pharmacy
2009 — 2013
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