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naukri

Senior Pharmacovigilance Specialist

Viatris
Riyadh, KSA
Senior
4 weeks ago
PharmacovigilanceICSR ManagementRegulatory ComplianceSafety Data CollectionQPPVClinical Trials
Free

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PharmacovigilanceICSR ManagementRegulatory Compliance
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Primary Job Function

  • Primary role as local QPPV for Viatris in KSA.
  • As Affiliate Safety Representative (ASR), accountable for execution, maintenance, and improvement of the PV system.
  • Ensure adherence to local and global processes and regulations.

Core Job Responsibilities

  • ASR and Local QPPV: Organize, implement, and maintain the Affiliate PV System.
  • After Hours Availability: Ensure after hours availability as per local regulation.
  • ICSR handling: Ensure local processes for ICSR management including receipt, documentation, forwarding, tracking, follow up.
  • Ensure collection of safety data for interventional studies and company initiated epidemiological programs.
  • Ensure screening of Viatris sponsored social media for safety information.
  • Ensure screening of local medical or scientific literature.
  • Ensure patient confidentiality and privacy compliance.
  • Ensure handling of safety information from internal teams, healthcare professionals, regulatory authorities.

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