Fortrea is a leading global contract research organization (CRO) that partners with biopharmaceutical, biotechnology, and medical device companies to drive healthcare innovation. With a strong focus on clinical trials, pharmacovigilance, and regulatory compliance, Fortrea ensures the highest standards of patient safety and data integrity.
Job Overview
The Functional Quality Specialist I plays a crucial role in ensuring compliance with quality standards in pharmacovigilance and safety reporting. The position involves reviewing safety cases, compiling quality metrics, assisting in client audits, and supporting regulatory submissions. The ideal candidate will have experience in pharmacovigilance, quality review, and knowledge of global safety regulations.
Key Responsibilities
- Perform quality review of assigned pharmacovigilance cases.
- Assist in compiling quality metrics and identifying trends.
- Support client quality reviews and regulatory submissions (PSURs, PADERs, Clinical Study Reports, etc.).
- Assist in Corrective and Preventive Actions (CAPA) implementation.
- Review expedited adverse events, product complaints, and medical information for compliance.
- Support client audits and regulatory inspections.
- Contribute to process improvements and training initiatives.
- Ensure adherence to GCP, GVP, ICH guidelines, and FDA/EU regulations.
- Manage medical information queries and product quality complaints.
Qualifications & Experience
Minimum Requirements:
- Education: Bachelor’s/Master’s/PhD in Medicine, Pharmacy, Life Sciences, or related fields.
- Experience: 2+ years in pharmacovigilance, safety writing, or quality review in pharma/biotech/CRO.
- Regulatory Knowledge: Familiarity with GCP, GVP, ICH guidelines, and FDA/EU regulations.
- Technical Skills: Proficiency in Microsoft Office.
Preferred Qualifications:
- Experience in quality metrics, CAPA management, and trend analysis.
- Knowledge of medical device reporting.
Work Environment & Physical Demands
- Office-based role with occasional travel (10%).
- Must comply with health and safety regulations (COSHH, EC Directives).
