Assoc. Dir.,PV Systems Reporting&Analytics(Contractor)(Remote)-TK9538
Job DescriptionJob Description
Company: Large Pharmaceutical Company in the Boston area.
Title: Assoc. Director, PV Systems Reporting & Analytics (Contractor)
Type: Contract Position - 5 months to start with potential extension
Work Style: REMOTE to EST/CST
Top skills: Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experience; Strong matrix management
Objectives:
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
Accountabilities:
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
Supervision: 1 worker indirectly.
Other:
Minimum of 10 years pharmaceutical or healthcare related industry experience required Minimum of 5 years pharmacovigilance or drug safety related experience Minimum of 5 years technical systems experience required in database report development, business intelligence, and/or data warehousing
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