Safety Science Coordinator I

Roles & Responsibilities
• Process Adverse Event (AE) and Serious Adverse Event (SAE) reports within agreed timelines
• Perform data entry, MedDRA coding, narrative writing, and listedness assessment
• Submit expedited safety reports (ESRs) to clients, regulatory authorities, ethics committees, and investigators
• Maintain adverse event tracking systems and project safety files
• Generate and resolve safety queries in coordination with medical teams
• Support preparation of Periodic Safety Reports (PSRs)
• Assist in database reconciliation and quality review of processed cases
• Ensure compliance with SOPs, WIs, regulatory guidelines, and Quality Management Systems
• Support archiving of safety study files and coordinate safety-related meetings
• Train and mentor junior team members and provide administrative support

Qualification
• Bachelor’s / Master’s degree / PharmD in Pharmacy, Life Sciences, Biological Sciences, Nursing, or related field
• Relevant safety or pharmaceutical/CRO industry experience may be considered in lieu of degree

Experience
• 0–2 years of pharmacovigilance or safety experience
• Experience in AE/SAE processing, narrative writing, MedDRA coding, or regulatory submissions preferred

Skills
• Knowledge of pharmacovigilance processes and regulatory requirements
• Strong attention to detail and data accuracy
• Good written and verbal English communication
• Ability to manage multiple tasks and meet strict timelines
• Proficiency in MS Office and safety databases
• Teamwork, logical thinking, and problem-solving skills

About the Organization
Fortrea is a global clinical development and patient access organization providing clinical research and safety services to pharmaceutical and biotechnology companies. The company focuses on delivering high-quality, compliant, and patient-centered solutions across the drug development lifecycle.