Ishika Gotarkar

Safety Science Analyst || Pharmacovigilance || Fortrea ||Labcorp ||Argus|| ARISg||

Role
Safety Science Analyst at Fortrea
Location
Pune, IN
LinkedIn followers
500 followers

About Ishika Gotarkar

As a dedicated and detail oriented professional with experience in the Pharmacovigilance domain, I have honed my skills in managing Individual case safety reports (ICSR), including triaging, classifying and coding adverse events using MedDRA.To strengthen my professional skills, I have completed a certification course in Pharmacovigilance, Clinical research, Clinical Data management, Medical Writing and Regulatory affairs from an ISO & MSME- Certified institute. Additionally I am proficient in tools like Aris g, Argus, MedDRA and Qbd software. My passion lies in contributing to patient safety and making a meaningful impact in the healthcare industry- Knowledge on medical terminology- Good understanding of ICH-GCP, GMP, GVP and FDA, 21-CFR guidelines- Good experience in Microsoft Office (Microsoft Excel, Microsoft Word)- Proficient in coding adverse event terms using MedDRA- Handling different types of case reports (spontaneous, solicitated, serious, non-serious and E2b)in compliance with regulatory timelines.

Experience

  1. Safety Science Analyst

    Fortrea

    May 2024 — Present

Education

  • Dr. Babasaheb Ambedkar Technological University

    Bachelor of Pharmacy - BPharm

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Ishika Gotarkar — Safety Science Analyst at Fortrea in Pune, IN | Unifers