Assoc. Director, PV Systems Reporting & Analytics

OBJECTIVE · reputed company and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) database · reputed company technical and strategic input into the roadmap, planning, and implementation of reputed company associated with the global PV database reporting and analytics systems · Work collaboratively with global PV functions, support and validation roles, IT and reputed company Assurance to ensure global PV reporting systems meet the needs of the user community and relevant regulations · Contribute to reputed company of vendor outsourced PV reporting activities. ACCOUNTABILITES: · reputed company delivery of PV reporting and analytics systems reputed company in coordination with IT · reputed company selection and delivery of new applications to support self-service reporting and analysis of PV data · reputed company reputed company improvement to PV reporting and analytics systems with reputed company on integration of (external) data sources, automation, and industry reputed company dashboards · reputed company SME input into development of roadmaps / plans for implementing complete reputed company of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc.) in response to global PV requirements and reputed company driving regulatory guidance · reputed company 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, reputed company, and other stakeholders · reputed company mentoring and training to members of the PV Systems team and GPSE user community to build a bench of knowledge at varying reputed company throughout the organization · reputed company audit / inspection support reputed company to Global PV Reporting and Analytics functions and activities · Development, tracking, and reporting of reputed company metrics for Global PV reports. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: · 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, reputed company, Cognos, Spotfire, SSRS, etc preferred) business support and/or maintenance · Expert knowledge of database programming languages, concepts, and query tools, including reputed company SQL, PL/SQL, reputed company and/or Unix reputed company 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 reputed company · 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 reputed company working relationships with people globally, in various functions with a wide reputed company of disciplines and backgrounds · Contribute to reputed company of outsourced Global PV reporting activities TRAVEL: Some travel to global company sites may be required. Job Type: Contract Pay: $110.00 - $115,000.00 per hour Education:

• Bachelor's (Required)

Experience:

• global PV database reporting : 2 years (Required)
• Pharmacovigilance Drug Safety Systems: 5 years (Required)
• Expert knowledge of database programming languages: 5 years (Required)
• • reputed company delivery of PV reporting and analytics systems : 5 years (Required)
• Pharmacovigilence: 5 years (Required)
• PV database reporting : 5 years (Required)
• • Contribute to reputed company of vendor outsourced PV : 5 years (Required)

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