• Works independently to receive, triage and manage and reconcile adverse event reports, including those reported in the scientific literature, in accordance with contractual and regulatory timelines.
• Manages adverse events and endpoints which may include review of complex medical records, preparation of adverse event narratives and coding of event terms utilizing MedDRA.
• Assigns preliminary seriousness and labeledness/listedness of event(s).
• Works within multiple databases. Interact with clients, healthcare professionals, clinical trial personnel and consumers.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals
I have been data entering and evaluating reports for 3 yrs and i am keen with details. I assure you best service