Pharmacovigilance Specialist
IQVIA
Taipei, Taiwan
1天前

Essential Functions

  • Performs safety case processing tasks including, but not limited to : Intake and triage tasks as performed by Clinical Safety Associate and / or Senior Clinical Safety Associate.
  • Reviewing incoming safety information for completeness and accuracy.
  • Tracking and data entry Writing clinical narratives Generating queries.
  • Contacting sites for missing and / or unclear information QC of cases.
  • Generating regulatory reports Reconciliation Generating metrics.
  • Serve as Safety Management key contact point on moderate to large sized studies / programs that are moderate to complex in scope of work with minimal guidance.
  • All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.
  • Attendance at team, client and investigator meetings
  • Presentations Training of staff on safety processes
  • Compliance with budget, including estimating monthly budget projections.
  • Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department managers
  • May assist with bid defenses or other presentations
  • May mentor and / or train new Safety Management staff Performs other related duties as assigned or requested by department management
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