Fortrea is a leading global contract research organization (CRO) committed to providing innovative solutions in clinical development and patient safety. With a strong focus on quality and compliance, Fortrea supports pharmaceutical, biotechnology, and medical device companies in bringing safe and effective treatments to market.
Job Overview
As a Safety Science Analyst at Fortrea, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products by managing adverse event reports from clinical trials and post-marketing surveillance. You will work closely with regulatory agencies, clients, and internal teams to ensure compliance with global safety regulations.
Key Responsibilities
1. Case Processing & Adverse Event Management
- Perform case intake and triage of safety reports from clinical trials and post-marketing sources.
- Conduct data entry of adverse events into safety databases.
- Write patient narratives and code adverse events using MedDRA (for marketed products).
- Assist in listedness assessment against product labels.
2. Regulatory Compliance & Reporting
- Submit expedited SAE reports to clients, regulatory authorities, and investigators within required timelines.
- Assist in the preparation and submission of periodic safety reports (PSURs, DSURs, etc.).
- Ensure compliance with ICH-GCP, FDA, EMA, and other global regulatory requirements.
3. Quality & Documentation
- Work within Quality Management Systems (QMS) and follow SOPs and Work Instructions (WIs).
- Maintain accurate documentation for adverse event reporting across different countries.
- Support database reconciliation and archival of case/study documents.
4. Collaboration & Compliance
- Build strong relationships with Pharmacovigilance (PV) and Clinical Safety teams.
- Ensure compliance with Health & Safety regulations, including COSHH and EC Directives.
Qualifications & Skills
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related field.
- Experience: Prior experience in pharmacovigilance, drug safety, or clinical research is preferred.
- Technical Skills: Knowledge of MedDRA, Argus, or other safety databases is a plus.
- Regulatory Knowledge: Familiarity with FDA, EMA, ICH-GCP guidelines.
- Soft Skills: Strong attention to detail, analytical thinking, and communication skills.
Why Join Fortrea?
- Work with a global leader in clinical research.
- Opportunity to contribute to patient safety and drug development.
- Career growth in pharmacovigilance and regulatory affairs.
- Competitive salary and benefits.
How to Apply
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