Prafulla Thakor

About Prafulla Thakor

In-depth knowledge of all applicable FDA/EMA/International/ICH-GCP safety reporting regulations and guidelines relating to Drugs, Biologics and Medical Devices• Achieve professional excellence in quality review, quality assurance and compliance of ICSR and PSR.• Proficient in using global safety databases (GSD) ARGUS, ARGUS AFFILIATE, SEPTRE, AWARE, PvMonitor and SINA• Contributed to safety management plan and risk management planning• Proficient MedDRA and WHO drug dictionary coder (4 years of experience in medical coding)• Worked on therapeutic areas such as oncology, cardiovascular, respiratory and endocrinology• Handled safety database migration (SINA –ARGUS affiliate) as well as up gradation (ARGUS 4.2-7) responsibilities • Act as a Subject Matter Expert (SME) for case processing and quality review• Knowledge of aggregate safety reports including PSUR, PADER, and DSUR submission• Awarded with ‘OPEL’, ‘WAH’, and S.M.A.R.T. awards in recognition of my overall performance in Cognizant Technology Solutions and Sciformix technology Pvt. Ltd.• Experience in clinical trial monitoring and review of clinical trial documents• Quality oriented, with attention to detail, Excellent player with ability to work in a team environment • Excellent written and verbal communication skills• Proven interpersonal, analytical thinking, organizational and time management skills

Experience

1. Associate Director, Global Pv Compliance Safety and Analytics

   Takeda

   Nov 2023 — Present · Cambridge, MA, US

   Provide support for compliance-related issues and advise PV management team of potential issues and solutions

Education

• Northeastern University

  Master’s Degree, Project Management (Regulatory affairs)

  2015 — 2017

• Orange lifesciences

  Diploma, Clinical research

  2009 — 2010

• North Maharashtra University

  Bachelor’s Degree, Pharmacy

  2004 — 2008

Skills

• Management
• Biotechnology
• Pharmacovigilance
• CRO Management
• CRO
• Pharmacovigilance and Drug Safety
• Medical Writing
• Gcp
• Medical Devices
• Clinical Research
• Validation
• Regulatory Submissions
• Clinical Trials
• Data Management
• Oncology
• Regulatory Affairs
• Protocol
• Pharmaceutical Industry
• Sop
• Clinical Development
• Life Sciences
• Ich-Gcp
• Good Clinical Practice (Gcp)
• Edc
• Pharmacology
• Clinical Data Management
• Standard Operating Procedure (Sop)