Kapil B. Email & Phone Number
Head of Pharmacovigilance Safety Operation and Compliance @ Asklepios BioPharmaceutical Inc
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Kapil B. Location
- Acton, MA, US
Kapil B. Work
- Head of Pharmacovigilance Safety Operation and Compliance @ (September 2023 - Present)
- Senior Director @ Inozyme Pharma (May 2023 - September 2023)
- Director, Compliance, Risk Management, Training and Strategy @ Medicago (December 2019 - April 2023)
- Associate Director @ (January 2018 - December 2019)
- Quality Assurance Manager @ (April 2016 - January 2018)
- Quality and Process specialist (audit and inspection readiness) @ (January 2013 - March 2016)
- PV compliance specialist @ (August 2012 - January 2013)
- Student at MS in Regulatory affairs @ (January 2011 - June 2012)
- Drug Safety Specialist and Database Integration Specialist @ Cubist Pharmaceuticals (June 2011 - May 2012)
- Junior Data Analyst @ (February 2009 - December 2010)
- Research Assistant @ (January 2008 - May 2008)
Kapil B. Education
- Northeastern University
MS (Regulatory affairs)
2011-2012 - Savitribai Phule Pune University
B.Pharmacy (Pharmacy)
2004-2008
Kapil B. Skills
- 21 CFR Part 11
- Analytical Skills
- Auditing
- Biotechnology
- CAPA
- CRO
- CRO Management
- CTMS
- Clinical Development
- Clinical Research
- Clinical Trial Management System (CTMS)
- Clinical Trials
- Corrective and Preventive Action (CAPA)
- Drug Development
- FDA
- GCP
- GMP
- Good Clinical Practice (GCP)
- HPLC
- High-Performance Liquid Chromatography (HPLC)
- ICH-GCP
- Leadership
- Life Sciences
- Lifesciences
- Management
- MedDRA
- Medical Affairs
- Medical Devices
- Medical Writing
- Oncology
- Pharmaceutical Industry
- Pharmaceutics
- Pharmacovigilance
- Project Management
- Protocol
- Quality Assurance
- Quality Control
- Quality Management
- Regulatory Affairs
- Regulatory Audits
- Regulatory Compliance
- Regulatory Requirements
- Regulatory Submissions
- SOP
- Standard Operating Procedure (SOP)
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Validation
- Visio
Kapil B. Summary
- Kapil B., based in Acton, MA, US, is currently a Head of Pharmacovigilance Safety Operation and Compliance at Asklepios BioPharmaceutical, Inc. (AskBio). Kapil B. brings experience from previous roles at Inozyme Pharma, Medicago and Alkermes. Kapil B. holds a 2011 - 2012 MS in Regulatory affairs @ Northeastern University. With a robust skill set that includes 21 CFR Part 11, Analytical Skills, Auditing, Biotechnology, CAPA and more. Kapil B. has 1 emails and 5 mobile phone numbers on RocketReach.
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