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About Company

As a leading global contract research organization (CRO), Fortrea combines scientific rigor with extensive clinical development experience. We offer pharmaceutical, biotechnology, and medical device clients a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a dedicated team of over 19,000 staff members operating in more than 90 countries, Fortrea is committed to transforming drug and device development for our partners and patients worldwide.

Position Name :

Safety Science Coordinator -1

Organization :



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


0 YEARS / Freshers


5 lacs Per Year


Pune, India

  • Case Intake and Triage:
    • Manage the intake and triage of incoming safety information or reports from various sources, including spontaneous reports and clinical trials.
  • Adverse Event Processing:
    • Data entry of safety data into adverse event tracking systems.
    • Write patient narratives and accurately code adverse events using MedDRA for marketed products, if applicable.
    • Assist in listedness assessments against appropriate labels for marketed products, if applicable.
  • Query Generation and Data Collection:
    • Generate queries and collect missing or discrepant information in consultation with medical staff as needed.
  • SAE Report Submission:
    • Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Fortrea project personnel within agreed timelines.
  • Report Processing and Submission:
    • Assist in the processing and submission of expedited and periodic reports to worldwide regulatory agencies and other recipients, ensuring adherence to regulatory and study-specific timelines.
    • Prioritize reports for processing and submission as required.
  • Database Reconciliation:
    • Assist in the reconciliation of databases as applicable.
  • Quality Management:
    • Work within the Quality Management System framework, including adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
  • Documentation Maintenance:
    • Assist in maintaining supporting files/documentation regarding adverse event reporting requirements in all countries, if applicable.
    • Support the upload and archival of case/study/project documentation as appropriate.
  • Relationship Building:
    • Build and maintain positive relationships across functional units within PSS.
    • Support compliance of operations with governing regulatory requirements.

Candidate Profile: Fortrea is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. We are dedicated to revolutionizing the development process and ensuring the swift delivery of life-changing therapies to patients. If you are looking to join an exceptional team and embrace a collaborative workspace where personal growth is nurtured, Fortrea is the place for you.

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