Assoc. Director, PV Systems Reporting & Analytics

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.

ACCOUNTABILITES:

· 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.

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, 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

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)
• • Lead delivery of PV reporting and analytics systems : 5 years (Required)
• Pharmacovigilence: 5 years (Required)
• PV database reporting : 5 years (Required)
• • Contribute to oversight of vendor outsourced PV : 5 years (Required)

Work Location: Remote

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