Associate Director, Pharmacovigilance Scientist @ (October 2019 - January 2021)
Pharmacovigilance Scientist @ (August 2018 - October 2019)
Manager, Drug Safety and Pharmacovigilance @ (April 2017 - August 2018)
Senior Safety Associate II @ (July 2016 - April 2017)
Senior Safety Associate @ (August 2014 - April 2017)
Safety and Benefit Risk Management Co-Op @ (January 2014 - June 2014)
Drug Safety and Risk Management Intern @ (June 2013 - August 2013)
Research Associate @ (May 2010 - October 2011)
Nisha Shah Education
Northeastern University
Master of Science (MS) (Regulatory Affairs in Drugs, Biologics and Medical Devices)
2012-2014
national institute of pharmaceutical education and research
M.S Pharm. (Biotechnology)
2008-2010
Nisha Shah Skills
Cell Culture
Molecular Biology
Tissue Culture
Protein Chemistry
recombinant DNA technology
Cell Based Assays
Cell Biology
Bioinformatics
Cell
Sop
Regulatory Affairs
IND
NDA
PMA
FDA GMP
FDA
CFR
ICH guidelines
Clinical Trials
Technology Transfer
GCP
Immunoassays
GMP
ICH-GCP
Ich Gcp
Reporting Requirements
Chemical
Adobe Contribute
Morphology
Protein Production
Clinical Research
Training Workshops
Biotechnology
Data Mapping
Influenza
Pharm
SEP IRA
RNA
Pharmaceutical Companies
Mammalian
Plaque Assay
Staining
Expedited
ELISPOT
Legal
Clinical Operations
Detection
Cancer
ANDA
Adverse Event Reporting
Regulatory Agencies
Management
Design
Science
Cellular Communications
Patient Safety
NIS
Boston
Emerging Trends
Informed Consent
Karyotyping
Isolation
System
Healthcare
Regulatory Knowledge
Combination Products
Reports
Biosimilars
Radiation Therapy
Fluorescence
Titration
Risk Management
Drug Development
Sds Page
FACS
Synopsis
CTD
Virus
Documentation
Quality Control
Research
Reporting
Investigation
Radiation
EMA
CAPA
Analysis
Microscopy
Raps
Gamma
Letters
Laboratory
Cell Lines
Experimentation
Perspective
Recombinant Dna
FIX Protocol
Tissue
Virus Culture
Data Collection
Communication
Baculovirus
DNA
MedDRA
Safety
Characterization
Purification
Operations
Regulatory Requirements
Posters
Quality System
Nces
Marketing
Beads
Indian
Bacterial Cell Culture
Data Logging
Project
IDE
Drug Safety
Pharmacy
Data Migration
Regulations
Biology
Pregnancy
Guidelines
Patient Outcomes
Medical Devices
Compliance
Pharmacovigilance
India
Pharmaceutics
AIM
Biologics
Pharmaceutical Industry
Insect
Negative
Evaluation
Propagation
Databases
Nisha Shah Summary
Nisha Shah, based in Littleton, MA, US, is currently a Executive Director, Pharmacovigilance Science and Risk Management at Cogent Biosciences. Nisha Shah brings experience from previous roles at Cogent Biosciences, Arcus Biosciences and Scholar Rock. Nisha Shah holds a 2012 - 2014 Master of Science (MS) in Regulatory Affairs in Drugs, Biologics and Medical Devices @ Northeastern University. With a robust skill set that includes Cell Culture, Molecular Biology, Tissue Culture, Protein Chemistry, recombinant DNA technology and more. Nisha Shah has 2 emails and 1 mobile phone numbers on RocketReach.
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