Sr. Scientist, Drug Safety (Bogotá)

Responsibilities

• 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...