Roles & Responsibilities
• Oversee receipt, processing, and reporting of adverse events from clinical trials and post-marketing sources
• Ensure timely and compliant submission of expedited and non-expedited safety reports to clients and regulators
• Process and support preparation of ICSRs, SAEs, DSURs, PSRs, Annual IND reports, and aggregate safety reports
• Maintain and work within safety databases as per Fortrea or client-specific conventions
• Support reconciliation of safety databases and workflow monitoring to meet project timelines
• Participate as safety lead on assigned projects and support cross-functional collaboration
• Prepare safety presentations, metrics, status reports, and quality documentation
• Support audits, inspections, TMF activities, and Safety Committees/DSMB data preparation
• Assist in development of SOPs, WIs, Safety Management Plans, and study-specific training materials
Qualification
• Non-degree / Associate / Bachelor’s / Master’s / PharmD in Life Sciences, Pharmacy, Nursing, Biological Sciences, Chemistry, or related fields
• Equivalent relevant industry experience may be considered
Experience
• 1–5+ years of Pharmacovigilance/Safety experience depending on qualification
• Hands-on experience in AE/SAE processing, safety databases, narratives, and regulatory submissions
Skills
• Strong knowledge of Pharmacovigilance processes and global safety reporting requirements
• Understanding of GCP, ICH guidelines, and worldwide regulatory requirements
• Knowledge of medical and drug terminology
• High attention to detail, strong communication, and organizational skills
• Proficiency in MS Office and safety systems
• Team-oriented with problem-solving and decision-making ability
About the Organization
Fortrea is a global Contract Research Organization (CRO) delivering clinical development, pharmacovigilance, and regulatory services. The company partners with life sciences organizations worldwide to ensure patient safety, regulatory compliance, and high-quality clinical outcomes.
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