Perform in-line medical safety review of individual case safety reports (ICSRs) and other adverse event reports of interest, as required per SOP, in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead. Conduct adverse experience reports review from specified sources in the safety database for regulatory reporting purposes.
Develop working knowledge of pharmacovigilance and regulatory reporting of ICSRs.
May perform medical review of other reports of adverse events as required, in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead.
May perform ICSR follow-up activities in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead.
May participate in process, quality, innovation, technology and other business-related activities under the guidance of ICMR Physician/Management.
May participate on special projects or rotational as...
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