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Pharmacovigilance Coordinator

PSI CRO - Sydney, NSW

Administration & Secretarial
Source: uWorkin


We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.

In this role, you will provide day-to-day support to the company’s Pharmacovigilance Unit and process safety information throughout the course of a clinical trial. You will help to enhance patient care and safety in relation to the use of novel pharmaceuticals.

Permanent / Full-time / Office-based

The scope of responsibilities will include:

  • Timely distribution of project-specific Serious Adverse Event (SAE) and Immediately Reportable Adverse Events (IRAE) reports to project teams
  • Data entry into the safety database
  • Non-medical review of incoming SAE and IRAE reports
  • Maintenance and update of the company's project-specific SAE distribution lists
  • Review of project-specific SAE trackers maintained by PSI project teams with focus on their timely update
  • A contact point for Safety Desk and clinical project teams regarding SAE and IRAE reports flow and filing
  • Interaction with IT personnel pertaining to safety line maintenance
  • Maintenance of Pharmacovigilance files, calendars and schedules in an orderly manner