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.
Nice to Have
- Knowledge of MS Office Windows applications.
Work Mode
This position offers a hybrid work arrangement.
Fortrea is an equal opportunity employer. Learn more about our EEO & Accommodations request here.
