Job Overview:
The Aggregate Report Specialist is responsible for supporting core pharmacovigilance deliverables, including scheduled and ad hoc aggregate reports, while ensuring high-quality, timely execution of assigned activities. The role involves collaboration with cross-functional stakeholders, quality review of reports, mentoring junior team members, and supporting process improvement initiatives.
Key Responsibilities:
Support the preparation, review, and coordination of aggregate reports, including PBRERs, PADERs, line listings, and other safety deliverables.
Conduct database searches and provide data analysis to support report generation and quality review activities.
Perform quality review of reports and source documentation, ensuring accuracy, compliance, and timely resolution of reviewer comments.
Collaborate with Global Safety, Regulatory Affairs, Medical Writing, Signal Detection, Epidemiology and other cross-functional stakeholders.
Monitor report timelines and calendars, escalate risks, and support project management activities.
Coach and mentor junior team members,



identify training needs, and contribute to quality improvement initiatives and CAPA activities.
Participate in team meetings, training, audits, inspections, and other departmental initiatives.​
Qualifications (Minimum Required):
First degree in life sciences.
Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.
Extensive knowledge of integral regulatory guidance (ICH, FDA, EMA) and demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
Proficiency with document management systems, Microsoft Office suite, including MS Project and MS PowerPoint, and other software/applications commonly used in industry for clinical, regulatory, and scientific communications activities.
Excellent command of written and spoken English.
Ability to independently lead writing projects

📌 Aggregate Report Specialist (Barcelona)
🏢 Fortrea
📍 Barcelona