Amit Gupta Email & Phone Number

Los Angeles, California

Manhattan, New York

Data Safety Monitoring Committee (DSMC) coordinator.Clinical trials registration on clinical trials.gov (CT.Gov).Serious adverse events reporting to FDA and pharmaceutical companies.

East Hanover, New Jersey

• Supporting clinical trial activities through study initiation and post study start up• Collection, reviewing, scanning and uploading of essential documents in eTMF (Trial Master File) including 1572 forms, financial disclosures, informed consents, IRB approvals, CV of principal investigator & sub- investigator and quality check for FDA compliance• Coordinate, manage and facilitate the activities related to the preparation, review and IRB Approval of country and site level regulatory documents, which are required to initiate a site into the trial• Maintain timely and comprehensive tracking of site follow-ups and study milestones via Study-Start-Up database (STARS & Gobalto)• Serve as the primary point of contact/liaison with Field Monitoring Operations and Drug Regulatory Affairs; pertinent to the administration of VDR and eTMF maintenance

Brooklyn, New York

* Assessment of recitation's assignments and in class assignments. Compilation of recitation record and examination paper and maintaining its confidentiality• Documentation of student's records using web-based course management system - Blackboard• Ensuring student's compliance with standards of the university and ensuring a quality exam by appropriate proctoring. Assisting the professor in his lectures and recitations

Sunnyvale, California

* Prepared summary format for clinical safety and efficacy studies* Reviewed, analyzed, extracted case report forms (CRF) and wrote clinical safety and efficacy narratives* Worked with cross-functional teams for completion and comparison of data cleaning and source documents

Mumbai Area, India

* Managed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines* Received, documented and processed adverse event (AE) reports from clinical trials, post-marketing and literature case in accordance with company Standard Operating Procedures (SOPs) * Performed initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database* Written, edited or summarised of ICSRs including spontaneous case reporting, Medical/Scientific literature cases, PMS study reports using Argus database* Ensured scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality* Prioritized timely case/expedited/periodic/regulatory/scheduled reports & sending to E2B, MedWatch, CIOMS, as well as other regulatory agencies* Performed manual coding of AEs using MedDRA dictionary for the events that were auto-encoded* Prepared clinical narrative summaries for AE reports independently from clinical studies and spontaneous post-marketing reports* Worked with Medical Reviewer, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and databased

Master’S Degree, Drug Regulatory Affairs, 3.85 / 4.0

Bachelor Of Pharmacy (Bpharm), Pharmacy