Assoc. Director, PV Systems Reporting & Analytics(Drug, )

Overview

Hybrid
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)

Skills

Drug
pharmacovigilance

Job Details

Assoc. Director, PV Systems Reporting & Analytics

Cambridge, MA (Hybrid)

Top Required Skills:

Argus Safety application and drug safety domain knowledge

Computer Systems Validation & SDLC experience

Strong matrix management skills

Job Description:

  • Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) database
  • Provide technical and strategic input into the roadmap, planning, and implementation of projects associated with the global PV database reporting and analytics systems
  • Work collaboratively with global PV functions, support and validation roles, IT and Quality Assurance to ensure global PV reporting systems meet the needs of the user community and relevant regulations
  • Contribute to oversight of vendor outsourced PV reporting activities

  • Lead delivery of PV reporting and analytics systems projects in coordination with IT
  • Lead selection and delivery of new applications to support self-service reporting and analysis of PV data
  • Lead continuous improvement to PV reporting and analytics systems with focus on integration of (external) data sources, automation, and industry standard dashboards
  • Provide SME input into development of roadmaps / plans for implementing complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc.) in response to global PV requirements and related driving regulatory guidance
  • Develop and ensure delivery of relevant PV reporting and analytics systems SOPs and training
  • Proactively identify PV reporting and analytics systems requirements in collaboration with business, IT, Quality, and other stakeholders ? Provide mentoring and training to members of the PV Systems team and GPSE user community to build a bench of knowledge at varying levels throughout the organization
  • Perform audit / inspection support related to Global PV Reporting and Analytics functions and activities
  • Development, tracking, and reporting of quality metrics for Global PV reports

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