Fortrea is a leading contract research organization that partners with pharmaceutical companies, biotechnology firms, and academic institutions worldwide to conduct clinical trials and research. Dedicated to advancing global health, Fortrea provides comprehensive solutions in clinical development, regulatory submissions, and safety monitoring.
Key Responsibilities of a Safety Science Analyst
As a Safety Science Analyst at Fortrea, you will play a critical role in the lifecycle of safety data management and regulatory reporting. Your key responsibilities will include:
- Case Intake and Triage
- Handle case intake and triage of safety information from various sources, including clinical trials and spontaneous reports.
- Adverse Event Processing
- Process adverse events (AEs) by entering safety data into tracking systems, writing patient narratives, and accurately coding adverse events using MedDRA.
- Perform listedness assessments against appropriate labels for marketed products when required.
- Safety Reporting
- Assist in the preparation and submission of expedited SAE (Serious Adverse Event) reports to clients, regulatory authorities, ethics committees, and investigators.
- Ensure timely submission of periodic reports to regulatory agencies and prioritize tasks based on regulatory timelines and study requirements.
- Quality Management & Documentation
- Work within the Quality Management System framework, adhering to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Maintain accurate documentation regarding adverse event reporting requirements and support database reconciliation as needed.
- Collaboration & Compliance
- Maintain professional relationships with cross-functional units within Fortrea.
- Ensure all operations comply with regulatory requirements, contributing to the overall safety and efficacy monitoring.
Essential Skills and Qualification
To be successful in this role, candidates should possess the following:
- Educational Background: A degree in Life Sciences, Pharmacology, or a related field is preferred.
- Experience: Not Mandatory but Prior experience in pharmacovigilance, safety science, or adverse event processing is beneficial.
- Technical Skills: Knowledge of MedDRA for coding adverse events, as well as familiarity with safety data management systems.
- Attention to Detail: Strong focus on detail to ensure accuracy in adverse event reporting and regulatory compliance.
- Communication: Excellent written and verbal communication skills to effectively coordinate with internal teams and external stakeholders.
- Regulatory Knowledge: Understanding of regulatory requirements for safety reporting, including SAE and adverse event protocols.
