Experience

Microsoft Cloud Community

• United Kingdom
• IT System Operations and Maintenance
• 500 - 600 Employee

• Drug Safety Scientist

  • Jun 2018 - Present

  Responsible for data entry of Individual case safety reports into the safety database.Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process all incoming cases in order to meet timelines.Full data entry including medical coding and safety narrative.Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Following up with sites regarding outstanding queries.Follow up on reconciliation of discrepancies.Follow departmental AE workflow procedures.Closure and deletion of cases.Literature review and processing of literature casesMentor and guide the activities of the Dug Safety Associate.Perform any other drug safety related activities as assigned.Submission of ICSRs to applicable regulatory authorities and licensed partners as per the agreed timelines. Show less

• Drug Safety Associate

  • Feb 2016 - Jun 2018

  Responsible for data entry of Individual case safety reports into the safety database.Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process all incoming cases in order to meet timelines.Full data entry including medical coding and safety narrative.Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Following up with sites regarding outstanding queries.Follow up on reconciliation of discrepancies.Follow departmental AE workflow procedures.Closure and deletion of cases.Mentor and guide the activities of the Dug Safety Associate.Perform any other drug safety related activities as assigned.Submission of ICSRs to applicable regulatory authorities and licensed partners as per the agreed timelines. Show less