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.