Pharmacovigilance Specialist

工作内容

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
  

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.