Shubham Harjule

Experience

• 

  Optum

  Nov 2023 - Dec 2023

  Medical Coder Trainee
• 

  Fortrea

  Dec 2023 - now

  Safety Science Analyst

  • Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. • Assist with processing of the adverse events, including but not limited to: • Data entry of safety data onto adverse event tracking systems. • Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable). • Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).• Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed.• Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.• Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines. • Assist in the reconciliation of databases, as applicable. • Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. • Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable. • Support upload/archival of case/study/project documentation, as appropriate. • Build and maintain good PSS relationships across functional units. • Support compliance of operations with governing regulatory requirements. • All other duties as needed or assigned. Show less