Pharmacovigilance Manager | ClinLab Staffing

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.

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