Director, OneHUB Product Safety Surveillance OUS

Added
7 days ago
Type
Full time
Salary
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Related skills

quality assurance vendor management audits gxp pharmacovigilance

📋 Description

  • Lead OUS AE and PQC intake across markets, time zones, and languages
  • Oversee end-to-end quality complaint intake and multilingual handling
  • Ensure timely, compliant AE/PQC documentation and routing
  • Manage vendor performance against SLAs and QC metrics
  • Forecast workload and staff across OUS markets within budget
  • Uphold pharmacovigilance, quality procedures, and GxP standards

🎯 Requirements

  • Bachelor’s degree in nursing or science; advanced degree desirable
  • 8+ years in clinical development/pharmacovigilance; 4+ years in management
  • Experience in OUS/international markets; cross-discipline exposure
  • Deep knowledge of clinical safety and/or PQC processes
  • Understanding of global/regional regulatory frameworks (EU, etc.)
  • Fluency with SOPs, regulations, outsourcing, and PV/PQC ops

🎁 Benefits

  • AbbVie’s comprehensive benefits package
  • Eligibility for long-term incentive programs
  • Equal opportunity employer; support for accommodations
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