USA - Data Scientist Architect

Job Description:-

Position Title: Assoc. Director, PV Systems Reporting & Analytics
Function: Global Pharmacovigilance
Department: Global PV Operations

OBJECTIVE:

• 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

• Bachelor s degree required; Advanced degree preferred
• Experience with Pharmacovigilance Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS, etc preferred) business support and/or maintenance
• Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc
• Strong understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing
• Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment
• Process oriented focus
• General knowledge of drug development process, including excellent knowledge of Pharmacovigilance regulations and guidance as applies to regulated PV computer systems
• Excellent analytical skills
• Excellent written and verbal communication skills
• Excellent organizational and time management skills
• Working knowledge of MedDRA
• Ability to establish sound working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds
• Contribute to oversight of outsourced Global PV reporting activities

• 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