Aggregate Report Specialist

About the role

The Aggregate Report Specialist supports core pharmacovigilance deliverables by preparing, reviewing and coordinating aggregate safety reports such as PBRERs, PADERs and line listings. The role works closely with Global Safety, Regulatory Affairs, Medical Writing and other cross‑functional teams to ensure high‑quality, timely reporting.

Key responsibilities

• Prepare, review and coordinate aggregate reports (PBRERs, PADERs, line listings, addenda).
• Conduct database searches and perform data analysis to support report generation.
• Perform quality review of reports and source documentation, ensuring compliance and timely resolution of comments.
• Monitor report timelines, manage calendars, escalate risks and support project management activities.
• Collaborate with Global Safety, Regulatory Affairs, Medical Writing, Signal Detection, Epidemiology and other stakeholders.
• Coach and mentor junior team members, identify training needs and contribute to CAPA and quality improvement initiatives.
• Participate in team meetings, trainings, audits, inspections and departmental projects.

Required profile

• First degree in life sciences (or equivalent experience).
• 6‑10 years of pharmacovigilance experience with hands‑on work on aggregate reports (PBRERs, PSURs, PADERs, addenda).
• Extensive knowledge of global regulatory guidance (ICH, FDA, EMA) and pharmacovigilance regulations.
• Excellent written and spoken English.
• Strong organizational, project‑management and analytical abilities.

Required skills

• Document management systems.
• Microsoft Office suite (Word, Excel, PowerPoint).
• MS Project.
• Statistical concepts and data review/QC capabilities.