Fortrea is seeking a Safety Science Analyst to assist with overall Clinical Safety and Pharmacovigilance System (PSS) operations. You will provide safety services to clients, ensuring quality and compliance with regulatory timelines and health and safety regulations.
What You'll Do
- Perform case intake and triage of incoming safety information from various sources.
- Assist with processing adverse events, including data entry onto safety tracking systems.
- Write patient narratives and code adverse events accurately using MedDRA.
- Assist in listedness assessment against the appropriate product label.
- Assist in generating queries and collecting missing information in consultation with medical staff.
- 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 databases.
- Work within the Quality Management System framework, including SOPs and Work Instructions.
- Assist in maintaining files and 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 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.
- PharmD with 0 years of Safety experience.
- Attention to detail.
- Team player with solid written and verbal communication skills.
- Accurate math and spelling skills.
- Ability to operate standard office equipment.
Nice to Have
- Knowledge of MS Office Windows applications.
- Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related area.
Technical Stack
- MedDRA
- Adverse event tracking systems
- MS Office Windows applications
Team & Environment
This role serves as a support function to client project groups or as a stand-alone business unit.
Work Mode
This position is hybrid.
Learn more about our EEO & Accommodations request here.
