Fortrea is hiring a Safety Science Analyst to provide critical support for Clinical Safety and Pharmacovigilance & Safety Systems (PSS) operations. You will assist in managing expedited adverse events and delivering safety data services, ensuring quality, safety, and adherence to regulatory deadlines.

What You'll Do

Perform case intake and triage of incoming safety information from various sources.
Assist with processing adverse events, including data entry into safety tracking systems.
Write patient narratives and code adverse events accurately using MedDRA (for marketed products, if applicable).
Assist in listedness assessment against the appropriate product label (for marketed products, if applicable).
Assist in generating queries and collecting missing or discrepant information.
Submit expedited SAE reports to clients, regulatory authorities, and other parties within agreed timelines.
Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies.
Assist in the reconciliation of safety databases, as applicable.
Work within the Quality Management System framework, including Standard Operating Procedures.
Assist in maintaining supporting documentation regarding adverse event reporting requirements.
Support upload and archival of case, study, and project documentation.
Build and maintain good PSS relationships across functional units.
Support compliance of operations with governing regulatory requirements.

What We're Looking For

Non-Degree with 6 months - 1 year of safety* or relevant** experience.
Associate Degree with 0-6 months of safety* or relevant** experience.
BS/BA with 0-6 months of safety* or relevant** experience.
MS/MA with 0 years of safety* or relevant** experience.
PharmD with 0 years of safety* or relevant** experience.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
To be used in lieu of experience, a degree must be in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related area.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives and queries, working within safety databases, and regulatory submissions.
**Relevant experience includes work in the pharmaceutical, biotechnology, or CRO industry, in areas such as Medical Affairs, Clinical Data Entry/Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Strong attention to detail.
Proven ability to be a team player.
Solid written and verbal communication skills.
Accurate math and spelling skills, with an aptitude for handling and proofreading numerical data.
Ability to operate standard office equipment.