Amit Shingarwade

Experience

• 

  Pentagon Research Pvt. Ltd.

  Apr 2014 - Sept 2014

  Clinical Research Coordinator

  Conducting clinical trials and communicate with laboratories or investigators. Perform specific protocol procedures. Record adverse event and side effect data, reporting of events and maintain required records of study activity.

• 

  Ipca Laboratories Limited

  Dec 2015 - Apr 2018

  Medical writing- Aggregate Reports including Periodic Adverse Drug Experience Reports (PADERs), Post marketing surveillance reports (PMS) and Periodic Safety Update Reports (PSURs) • Compilation of data for Aggregate Reports including Line Listing and Summary Tabulation. • submission of aggregate reports. Quality review of ICSR. Triage the adverse event reports. Literature monitoring activity, registration of cases, Procurement and translation of full text articles, Duplicate search and registration of ICSR. MLM on Eudravigilance database. Follow-up and query of spontaneous, clinical, PQC and BABE cases. Reconciliation

  • Drug Safety Executive

    Jan 2017 - Apr 2018

  • Drug Safety Associate

    Dec 2015 - Dec 2016
• 

  Cipla

  Apr 2018 - Nov 2020

  Aggregate Writing - Pharmacovigilance

  Drafting , Review and submission of Aggregate Reports ( PSUR, PADER, PBRER, RMP, ADCO) and other relevant work

• 

  JB

  Nov 2020 - now

  PBRER, PSUR, PADER, RMP, Safety Reports, SDEA, SOP, SmPc, PIL

  • Assistant Manager

    Apr 2023 - now

  • Aggregate Reports - Pharmacovigilance

    Nov 2020 - Mar 2023