Roles & Responsibilities
• Perform quality review of safety cases, regulatory documents, and pharmacovigilance reports
• Compile quality metrics, identify trends, and support client quality reviews
• Assist in CAPA preparation, implementation, and effectiveness monitoring
• Review adverse events, product quality complaints, and medical information cases within timelines
• Support audit readiness, regulatory inspections, and quality management activities
• Conduct data analysis and contribute to process improvement initiatives
• Assist in training coordination, documentation review, and QC activities
• Support reconciliation of safety data and regulatory documentation compliance
Qualification
• Bachelor’s / Master’s / PhD in Medicine, Pharmaceutical Sciences, Life Sciences, Nursing, or related discipline
Experience
• Minimum 2+ years of experience in Pharmaceutical, Biotechnology, or CRO industry
• Experience in Pharmacovigilance, Safety Writing, or Quality Review preferred
Skills
• Knowledge of Pharmacovigilance processes and safety reporting requirements
• Understanding of GCP, GVP, ICH, EU, and FDA regulatory guidelines
• Strong attention to detail and documentation review skills
• Good analytical, communication, and problem-solving abilities
• Proficiency in MS Office and safety data management tools
About the Organization
Fortrea is a global Contract Research Organization (CRO) providing clinical development, pharmacovigilance, and regulatory support services. The company partners with life sciences organizations to deliver high-quality, compliant solutions that improve patient safety and accelerate drug development.
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