Dr. Sonika Mittal Email & Phone Number

Healthcare professional with over 8 years of experience, including 6+ years specifically in Pharmacovigilance (PV) managing individual case safety reports (ICSRs) of various types such as clinical trials, spontaneous reports, and solicited programs.•Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation).•Proficient with safety databases like Argus and Aware for effective case management and reporting of adverse events.•Conducting duplicate searches prior to registration and identifying potential duplicates in client’s screening database and classifying reports as new or follow up reports•Performing triage of reports to determine if they qualify for expedited reporting and the timelines within which they need to be submitted to the regulatory authorities•Performing clear and accurate data capture of reports and appropriate medical assessment (including company causality) of cases in accordance with client and data mangement conventions•Coding of Individual case safety reports in the safety data base, including determining the expectedness of adverse events against various labelling documents (such as Investigator brochure (lB) etc.).•Submitting reports of valid AEs to Health Canada and FDA as per regulatory requirements.•Working in collaboration with cross functional teams to develop and implement corporate communications, educational presentations and training material.

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  Baba Farid University Of Health Sciences, Faridkot

  Bachelor Of Dental Surgery