Pranav Bhandarkar

Experience

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  AXA

  Nov 2005 - Aug 2009

  Process Lead
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  Synowledge LLC

  Mar 2012 - Aug 2014

  Senior Drug Safety Associate

  Mainly worked using Aris G database platform to perform the below mentioned responsibilities:- Receive, follow-up and report adverse events- Review and process adverse events reported by Investigators - Prepare Safety report as per Schedule-Y format to be reported to regulatory authorities and also other Investigators, who are part of the study- Research and provide medical and scientific information to health care professionals and to various functional areas within the company- Conduct and analyze, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries- Review clinical trial protocols, bioequivalence study protocols and provide inputs, support the clinical trial team- Generates concise, accurate and well-written case narratives - Responsible for effective and efficient development of the safety management plan, including development of specific processes to assure consistency within the project - Effectively maintains the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process- Performs consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions - Supports the generation of Annual Safety Updates, Periodic Safety Reports, and other cumulative safety reports including data retrieval, analyses and quality control - Reconciles SAEs in accordance with project specific guidelines - Represents team at client meetings; contributes presentation of safety process at investigator meetings • Types of cases handled: Spontaneous, Study, Market research, literature and E2B cases.• Quality control (QC), cases were revised and checked completely after case processing based on the client conventions and sent to the next level for submission to client.• Identifying clinically relevant missing information and initiate follow-ups Show less

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  MResult

  Aug 2014 - Dec 2019

  Senior Analyst

  Providing Reporting assistance, along with insights on performance of clinical trial operations for pharma companies. The insights provided are used to better the performance of functional service providers for the companies as well as internal operations.

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  Agilisium Consulting

  Apr 2020 - now

  • Senior Manager

    Oct 2024 - now

  • Data & Business Analyst Manager

    Oct 2023 - Nov 2024

  • Lead Business Analyst

    Apr 2020 - Nov 2024