• 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.
• Maintain medical understanding of applicable therapeutic area and disease states. May participate in on-call duties for specific projects to ensure 24-hr coverage of safety reporting.
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
• Prepares and maintains regulatory and safety reports.
• Assists with routine project implementation and coordination (e.g., Clinical trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
• Mentors less experienced staff.
• Performs other duties as assigned.
• Process reports for new clinical trial drug under Biogen.