Pharmacovigilance Manager

Responsibilities of the Pharmacovigilance manager include but are not limited to:

• Safety Management Plan compilation
• Review of medical records for serious adverse event reporting
• Writing clinical narratives and FDA MedWatch form 3500 (if applicable)
• Reconciliation of clinical database entries with safety data.
• Clinical Data listing review with project team
• Liaise with medical monitor for safety review/finalization of serious adverse events.
• May participate in open-session Data Safety Monitoring Board meetings (if applicable)
• May participate in medical and concomitant medication coding review
• Effective communication between site staff, sponsor, internal staff members
• Participate in project team meetings
• Knowledge of FDA/GCP regulatory requirements
• Knowledge of Excel, Word and ACCESS
• Other special projects as assigned by Senior Management

Background in nursing or other clinical field required.