Safety Specialist
Was responsible for coordinating and performed adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database.• Reviewed entered cases for quality, consistency, and accuracy, follow up with reporter and/or associated Healthcare provider (HCP), tracking of reports, and reporting activities. • Coded adverse event terms and write narratives according to client convention. • Assisted with preparation and review of regulatory reports and SAE reconciliation. • Reviewed literature articles/abstracts and processed adverse event reports from literature per program and regulatory requirements. • Represented pharmacovigilance (PVG) at kick off meetings, hand off meetings and Investigator meetings for assigned project. • Reviewed and understood assigned study specific budgets.