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Lets do this. Lets change the world. In this vital role you will manage changes to the global safety system and associated datamarts in Global Patient Safety reporting to a GPS Director. This role will manage the implementation of global safety system configurations. Ensure data integrity to support data analytics/reporting and manage the training of technical and business users for data analytics/reporting functionalities and associated processes

Responsibilities

• Serve as Business Owner for the global safety system, add associated interfaces and datamarts to ensure the development, administration, and operation with collaboration of IS
• Drive process and safety systems-related change through established governance forums
• Partner with cross-functional collaborators in GPS, GDO and other relevant functions to establishment data integrity to support data analytics and data reporting tools
• Provide Safety Data Analyst (SDA) oversight of safety system configuration and output generating
• Lead timeliness and quality of SDA deliverables
• Lead SDA internal staff, contracted resources and budget
• Chip in to efforts to improve processes and increase work efficiency applicable to the SDA responsibilities
• Provide input to the development and maintenance of SOPs and other process documents
• Contribute to the development and delivery of training related to safety system and tools
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Supports inspection and audit activities, and the co-ordination of global safety system outputs and written responses to findings as required within remit of role

We are all different, yet we all use our unique contributions to serve patients. The Safety Data Analyst professional we seek is a leader with these qualifications.

Basic Qualifications

Doctorate degree and 2 years of experience Or Masters degree and 6 years of experience Or Bachelors degree and 8 years of experience Or Associates degree and 10 years of experience Or High school diploma / GED and 12 years of experience And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• In depth knowledge of safety systems as well as query and reporting tools
• Understanding of Oracle database, Oracle Developer, and standard programming languages
• Understanding of software development lifecycle and development standards, including validation methodology
• Understanding of global regulatory requirements for pharmacovigilance and safety reporting
• Understanding of Clinical Trial and Pharmacovigilance Processes
• Familiarity with statistical analysis and interpretation of aggregate safety data
• Personnel Management
• Organization, prioritization, planning and measurement of work delivery
• Ability to establish relationships and work cross-functionally
• Work independently; recognize and raise issues
• Pharmaceutical industry or health authority experience.
• Experience in supporting inspections or internal audits
• Written and oral communications, leadership and problem solving