Naisargee Shah
A pharmaceutical scientist with in-depth knowledge of clinical trial design and management, GCP, GMP...
San Francisco, California, United States
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Naisargee Shah’s Email naisargiparikh@yahoo.co.in
Social Media
Naisargee Shah’s Location San Francisco, California, United States
Naisargee Shah’s Current Industry Beigene
Naisargee Shah’s Prior Industry Rain Oncology | Rain Therapeutics | Puma Biotechnology | Cordis | Stanford University School Of Medicine | Stealth Mode Startup | Department Of Science And Technology Govt | Bristol Myers Squibb | Pharmanza Herbal
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Work Experience
Beigene
Director, Clinical Science and Development
2024-01-01 00:00:00 - Present
Rain Oncology
Sr Director
2022-06-01 00:00:00 - 2023-11-01 00:00:00
Rain Therapeutics
Director, Clinical Science and Development
2021-04-01 00:00:00 - 2022-06-01 00:00:00
Puma Biotechnology
Associate Director, Clinical Science and Development
2019-09-01 00:00:00 - 2021-04-01 00:00:00
Cordis
Clinical Scientist
2017-08-01 00:00:00 - 2019-09-01 00:00:00
Stanford University School Of Medicine
Clinical Research Coordinator
2016-09-01 00:00:00 - 2017-08-01 00:00:00
Stealth Mode Startup
Principal Scientist & Project Lead
2014-01-01 00:00:00 - 2015-01-01 00:00:00
Department Of Science And Technology Govt
Senior Research Fellow
2009-07-01 00:00:00 - 2013-11-01 00:00:00
Bristol Myers Squibb
Bristol Myers Squibb Fellow
2008-07-01 00:00:00 - 2009-06-01 00:00:00
Pharmanza Herbal
Research Trainee at QA/QC Department
2007-04-01 00:00:00 - 2007-07-01 00:00:00Skills
Languages
FAQ About Naisargee Shah
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Naisargee Shah is located at
San Francisco, California, United States -
Naisargee Shah is a A pharmaceutical scientist with in-depth knowledge of clinical trial design and management, GCP, GMP, GLP and regulatory guidelines (FDA, EMEA, ICH) for conducting/managing a clinical trials Well versed with - USA, Europe, China, ICH and other global regulatory bodies and their regulations - Different components of clinical trial: recruiting, screening, consenting, doing follow up and conducting/assisting study start-up, interim and closing visits and working closely with IRB/IEC - Creating, filing and managing study protocol, investigational brochure, ICF/eICF, CRF/eCRF, trial master file and other source documents - Causality assessment, and adverse event and safety reports, IND safety report/IND annual report - Monitoring clinical trial site and performing source document verification - Regulatory filling for drugs: IND, NDA(505(b)(i), 505(b)(ii)), ANDA (505(j)(i)), BLA, CTA and MAA - Regulatory filling for medical devices: PMA, 510(k), IDE, HDE, - Centralized, decentralized, nationalized or mutual recognition procedure application procedures - Standard, priority, accelerated, fast tract, break through therapy approaches - CMC, CTD/eCTD and different components of dossier submission - ICH, GCP, GMP and GLP guidelines
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Naisargee Shah currently works in the Beigene |
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No Languages Available
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Naisargee Shah has prior
experience in the following industries:
Rain Oncology | Rain Therapeutics | Puma Biotechnology | Cordis | Stanford University School Of Medicine | Stealth Mode Startup | Department Of Science And Technology Govt | Bristol Myers Squibb | Pharmanza Herbal -
Naisargee Shah has the following professional experience:
Beigene | Rain Oncology | Rain Therapeutics | Puma Biotechnology | Cordis | Stanford University School Of Medicine | Stealth Mode Startup | Department Of Science And Technology Govt | Bristol Myers Squibb | Pharmanza Herbal -
You can view Naisargee Shah’s LinkedIn profile at LinkedIn URL
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Naisargee Shah’s work email
addresses are
naisargiparikh@yahoo.co.in -
Beigene |
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