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Master's of Medical Biology (Medical Chemistry)

Long Island University

Email:ishipatel85@gmail.com



ISHITA PATEL


SKILLS

  • DRUG SAFETY DATABASE: ARGUS, MedDRA v.14.1
  • COMPUTER SKILLS: Application: MS Office, Operating Systems: Windows 98, Windows XP
  • TECHNICAL: OC RDC 4.5, INFORM 4.6


    PROFESSIONAL EXPERIENCE

    ClifoMatrix- Flemington, NJ            Jun 2011- Present

    Drug Safety Associate

    BioBridges LLC-Boston, MA            Aug 2010- May 2011

    Drug Safety Associate

  • Ensure effective reconciliation with clinical and safety databases (ARGUS)
  • Suggested and implemented quality improvement measures in case processing
  • Assessed and generated non-serious solicited and spontaneous cases
  • Obtained follow-up SAE information from clinical sites and CROs and responded to queries.
  • Processed cases using MedDRA and WHO-DRUG coding dictionaries
  • Ensured report, file, and database accuracy and completed all work within acceptable quality standards and determined timelines
  • Submitted expeditable safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to the EudraVigilance database (EV Web application or Gateway)
  • Generates data listings from the safety database and assumes responsibility for accuracy of the data
  • Gathered information from a variety of global sources, including clinical trials, spontaneous, in compliance with company SOPs, U.S. and international regulations within strict timelines
  • Collaborated with physicians to manage case handling assessments
  • Regularly participated in quality improvement sessions to ensure efficiency and timeliness
  • Managed and maintain up to date case processing standards, ensuring accuracy


    EDUCATION

    Masterís of Medical Biology (Medical Chemistry)
    Long Island University, Brookville NY-USA

    Bachelor of Science in Pharmacy
    A.R.College of Pharmacy, V.V. Nagar, Gujarat INDIA










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