Safety & PV Specialist I
1 week ago
• Process and triage Individual Case Safety Reports (ICSRs)
• Ensure data accuracy, completeness, and regulatory compliance
• Code medical events, histories, and medications using MedDRA
• Support xEVMPD submissions and SPOR/IDMP activities
• Maintain documentation in TMF and PV system master files
• Collaborate cross-functionally and support audits
Must-Have:
• Hands-on experience with Argus or ArisG safety databases
What You Bring:
• Strong understanding of PV regulations, GVP, GCP, and ICH guidelines
• Familiarity with global regulatory reporting requirements
• Excellent attention to detail and communication skills
• Ability to work independently and in a team environment
Join a team that values compliance, collaboration, and continuous learning.
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