Safety Science Coordinator I

Roles & Responsibilities:
• Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
• Maintain adverse event tracking systems and project documentation
• Enter safety data, write patient narratives, and code adverse events using MedDRA
• Perform listedness assessment against product labels, as applicable
• Submit AE/SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, and internal teams within timelines
• Assist with peer/quality review of processed reports and support trend analysis
• Reconcile databases and maintain regulatory safety files
• Prepare and coordinate safety study files for archiving
• Train and mentor PSS Assistants or peers in daily activities
• Ensure compliance with SOPs, Quality Management System, and regulatory requirements
• Provide administrative support and build good relationships across functional units

Qualification:
• Non-degree with 1–2 years of Safety experience, or
• Associate degree with 1 year of Safety experience, or
• PharmD with 0–6 months of Safety experience

Experience & Skills:
• Experience in AE/SAE processing, narratives, queries, safety databases, and regulatory submissions preferred
• Relevant experience in Pharma/CRO/biotech in Clinical Data, Medical Affairs, Regulatory, or QA is acceptable
• Good team player, attention to detail, and ability to prioritize tasks
• Strong written and verbal communication skills in English and local language
• Proficient with MS Office and standard office equipment

About the Organization:
Fortrea is a global life sciences services company providing high-quality clinical safety, regulatory, and PSS support to pharmaceutical and biotechnology clients.