Vakar

WORK HISTORY

EDUCATION

ABOUT VAKAR

I have about 5 years of PV experience in the management of ICSRs Including (Spontaneous, Clinical trial studies) which includes duplicate search, triage, Book in, data entry, and reviewing data entry of ICSRs using the safety database (ARGUS, JASPER)- Triaging of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submit to the regulatory authorities and data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents such as Summary of Product Characteristics (SPC), Core Data Sheet (CDS), Investigator\'s Brochure (IB), USPI etc, writing case summaries/Narrative, assessing causalities and writing company comment if required- Trained in Medical Dictionary for Regulatory Activity (MedDRA) coding in accordance with “MedDRA Term Selection: Points to Consider”- Maintaining a good working knowledge of the adverse event safety profile of assigned drugs/vaccines, Reference Safety Information documents, data entry conventions and guidelines, clients procedures, and international drug safety regulations including -the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on safety and efficacy -United States Food and Drug Administration (FDA) guidelines -Council for International Organizations of Medical Sciences (CIOMS)-European Union Good- Pharmacovigilance Practice (EU GVP) guidelines- Other areas of performance are Management of team, end-to-end PV activities, Mentoring, providing Training to PV staff and Mentoring new team members so that they reach their full potential. Support/implement quality initiatives as appropriate.