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.