Fortrea is a leading global contract research organization (CRO) dedicated to advancing scientific rigor and clinical development. With decades of experience, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to deliver innovative clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in 100+ countries, Fortrea is transforming drug and device development to improve patient outcomes worldwide.
Job Overview: Safety Science Analyst
As a Safety Science Analyst at Fortrea, you will play a critical role in ensuring the safety and efficacy of clinical trials and post-marketing products. You will be responsible for managing and processing adverse event reports, ensuring compliance with regulatory requirements, and supporting global safety operations. This role is ideal for individuals passionate about patient safety, regulatory compliance, and clinical research.
Key Responsibilities
- Case Intake and Triage:
- Receive and triage safety information from clinical trials and post-marketing sources.
- Ensure accurate and timely processing of adverse event reports.
- Adverse Event Processing:
- Perform data entry of safety data into tracking systems.
- Write patient narratives and code adverse events using MedDRA (for marketed products).
- Conduct listedness assessments against product labels.
- Regulatory Submissions:
- Submit expedited SAE reports to clients, regulatory authorities, and ethics committees within agreed timelines.
- Assist in the preparation and submission of periodic safety reports.
- Quality and Compliance:
- Work within Fortrea’s Quality Management System (QMS), adhering to SOPs and Work Instructions.
- Ensure compliance with global regulatory requirements.
- Collaboration and Support:
- Build strong relationships with Pharmacovigilance and Safety Science (PSS) teams.
- Support reconciliation of safety databases and archival of case/study documentation.
Qualifications and Skills
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- Experience in pharmacovigilance, clinical research, or drug safety is preferred.
- Proficiency in MedDRA coding and adverse event reporting systems.
- Strong attention to detail and ability to meet tight deadlines.
- Excellent communication and teamwork skills.
