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 general 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 indepen

📌 Aggregate Report Specialist (Barcelona)
🏢 Fortrea
📍 Barcelona