DSPV Training and Compliance Administrator

Location: Cambridge, Massachusetts, United States
Salary: competitive
Sectors: Operations
Job Type: Contract
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Job Summary:

The DSPV Training and Compliance Administrator will be an integral role in design, development, and maintenance of PV training curriculum, and deviation/CAPA management activities. The DSPV Training and Compliance Administrator will partner closely with other functions to ensure procedural and Regulatory compliance.

Primary Responsibilities:

  • Supports all PV and departmental training related activities
  • Development and maintenance of training curriculum/matrices
  • Leads the development and changes for SOPs/WI/Other quality documents
  • Creates and delivery training content as needed
  • Tracks and reports training metrics
  • Monitors new training assignments and maintains training forms and JDs/CVs as needed
  • Perform ongoing needs analysis to ensure learning solutions meet and/or exceed compliance requirements
  • Identify gaps in Pharmacovigilance system, supports solutions, and monitor completion
  • Support PV inspection readiness activities and coordinates for global inspection readiness
  • Reviews audits/inspections findings to ensure accuracy and quality effectiveness checks
  • Partners with DSPV, Quality and third-party vendors on deviation/CAPA management activities

Additional Skills

  • Knowledge of US/EU/MHRA/AP Regulations & GVP-ICH Guidelines
  • Strong written and verbal communication
  • Cross-functional collaboration
  • Alliance management
  • Independent/self-motivated
  • Strategic thinker
  • Pharma/Biotech experience
  • Pharmacovigilance experience
  • Familiar with Safety Database activities

Sthree US is acting as an Employment Business in relation to this vacancy.

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