31 Jul
|
Fortrea
|
Bengaluru
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers 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.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers 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.
Job Description:
Assist in the processing of Expedited Safety Reports (ESRs),
Periodic Safety Reports (PSRs) and submission, including but not limited to:
Maintenance of adverse event tracking systems
Set-up and maintenance of project files, and central files for documentation.
Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines.
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)
Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed
Submission of expedited SAE reports t
📌 Safety Science Coordinator Bengaluru
🏢 Fortrea
📍 Bengaluru