Clinical Safety Specialist

4 days ago


Pune, Maharashtra, India Fortrea Full time

Job Overview:

Fortrea seeks a skilled Clinical Safety Specialist to assist with the overall clinical safety and operations associated with products. The successful candidate will manage and process expeditable adverse events to the required standard and submit them to the client and/or regulatory agencies within agreed timelines.

Key Responsibilities:

  • Perform case intake and triage of incoming safety information or reports from various sources.
  • Process adverse events, including data entry onto adverse event tracking systems, writing patient narratives, and coding adverse events accurately using MedDRA.
  • Assist in generating queries and collecting missing or discrepant information in consultation with medical staff.
  • Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and other recipients within agreed timelines.
  • Work within the Quality Management System framework, including Standard Operating Procedure (SOP) and departmental Work Instructions (WIs).

Requirements:

  • Non-degree or 6 months - 1 year of safety experience, or relevant experience.
  • Associate Degree with 0-6 months of safety experience, or relevant experience.
  • BS/BA with 0-6 months of safety experience, or relevant experience.
  • MS/MA with 0 years of safety experience, or relevant experience.
  • PharmD with 0 years of safety experience, or relevant experience.

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