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About Company

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Position Name :

Safety Science Analyst

Organization :

Fortrea

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

0 to 2 Years

Salary:

₹4.8 Lakhs

Location:

Bangalore

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.

Application Link