As a Safety Science Analyst, you will assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process. This may involve safety data collected from clinical trials and/or post-marketing settings. You will manage and process expeditable adverse events to the required standard and submit them to clients and/or regulatory agencies within the agreed timelines. The role demands providing clients with the appropriate quality of service in a safe and cost-effective manner.

Key Responsibilities:

• Perform case intake and triage of incoming safety information or reports from various sources.
• Assist with processing adverse events, including:
  • Data entry of safety data onto adverse event tracking systems.
  • Writing patient narratives and coding adverse events accurately using MedDRA.
  • Listedness assessment against appropriate labels for marketed products.
  • Generating queries and collecting missing or discrepant information in consultation with medical staff.
• Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel within agreed timelines.
• Assist in the reconciliation of databases.
• Work within the Quality Management System framework, including Standard Operating Procedures (SOP) and departmental Work Instructions (WIs).
• Maintenance of supporting files/documentation regarding adverse event reporting requirements in all countries.
• Support upload/archival of case/study/project documentation.
• Build and maintain good PSS relationships across functional units.
• Support compliance of operations with governing regulatory requirements.
• Perform all other duties as needed or assigned.

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