Safety Aggregate Report Coordinator Associate
Core
Project management of safety aggregate reports submitted to regulators (FDA, EMA) to ensure timely completion and regulatory compliance.
Role type
Associate project coordinator (regulatory safety reporting)
Builds
Regulatory safety aggregate reports for FDA and EMA
Domain
Pharmaceutical industry / Regulatory affairs
Required skills
Project management, Data review and consistency checking, Document compilation, Regulatory compliance knowledge, Cross-functional collaboration, User Acceptance Testing (UAT)
Preferred skills
Business Objects/Business Intelligence, Knowledge of regulatory/safety regulations
Technologies
Microsoft Office (Word, PowerPoint, Excel, Outlook, Teams), SharePoint, Adobe PDF
Responsibilities
Lead report preparation from prep to submission, Review data for consistency, Compile information using electronic tools, Coordinate review and approval processes, Ensure reports meet regulatory due dates, Provide guidance on report requirements, Participate in UAT
Seniority
Associate, individual contributor