Shifa Begum

Well experienced in intake and triage activity, case processing, quality control, with good knowledge in medical coding, narrative writing, reconciliation. Competent communication skills and excellent team player.

Senior Drug Safety Associate at Qinecsa (2022-03 – Present)

Responsible for Email intake, case intake, duplicate check, and registration of the case into the safety database. Maintains log of source documents and other communications. Handling the deletion process. Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary. Follow up on reconciliation of discrepancies. VIVA Vault, MEDRA, SDEA, Literature search.

• Responsible for Email intake, case intake, duplicate check, and registration of the case into the safety database
• Maintain log of source documents and other communications. Handling the deletion process
• 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)
• Follow up on reconciliation of discrepancies
• VIVA Vault, MEDRA, SDEA, Literature search

Safety science coordinate II at Labcorp (2021-03 – 2022-03)

Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source. Assist Data Management or clients on reconciliation of safety databases. Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), work instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.

• Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source
• Assist Data Management or clients on reconciliation of safety databases
• Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), work instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance

Drug safety associate at Bioclinica (2018-07 – 2021-01)

Review data entered in safety database for completeness and accuracy with reference to source documents as per applicable SOPs, work instructions and client guidelines. Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures.

• Review data entered in safety database for completeness and accuracy with reference to source documents as per applicable SOPs, work instructions and client guidelines
• Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures

Bachelors in Pharmacy – NITTE Gulabi Shetty Memorial Institute of Pharmaceutical Sciences (2014-07 – 2018-06)

MBA in Hospital and healthcare administration – Dr. D. Y. Patil Vidyapeeth, Centre For Online Learning (2022-04 – 2024-03)