Job Title -Manager - Patient Safety Systems
Career Level - D
Introduction to role
Global Patient Safety Technical Solutions (PSTS), part of Global Patient Safety Operations, Technology and Analytics, is responsible for managing the information assets and systems owned by CMO, ensuring effective governance across the enterprise. We deploy technology and systems to drive business value within Global Patient Safety and the larger R&D organization. Reporting to the ARGUS Business Interface Team (ABI), the Pharmacovigilance Systems Expert will work within AstraZeneca’s pharmacovigilance (PV) case handling systems and technologies built upon Oracle’s ARGUS platform. The ideal candidate will have strong experience with systems and software management, a working understanding of quality management, and ideally a background in life sciences. Experience in PV would be highly beneficial.
System Design: Contribute to the development and design of PV systems in line with regulatory obligations and business objectives of Global Patient Safety.
Installation Oversight: Supervise the installation of new components or upgrades to existing components, ensuring compliance with industry standards and safety regulations.
Maintenance and Troubleshooting: Perform regular maintenance and troubleshooting of systems to ensure optimal performance and longevity.
Technical Support: Provide technical support and guidance to system user community and partners such as IT.
Project Management: Oversee and contribute to the completion of obligatory system updates and technology upgrades.
Compliance and Documentation: Ensure all systems comply with local, state, and federal regulations. Maintain accurate documentation and records of all installations and maintenance activities.
Training and Education: Train and educate users and team members on optimum operation of PV technologies.
Bachelor’s degree in a scientific discipline, with relevant experience in supporting safety-related activities in the context of clinical biopharmaceutical development.
Proven experience and competence, with involvement in the successful design, delivery, deployment or maintenance of information/systems solutions.
Working knowledge or experience in life sciences and validated computerized systems, preferably within patient safety/pharmacovigilance.
Experience in system validation.
Higher degree in a clinical or safety-related discipline.
Experience in pharmacovigilance with a proven record of supporting safety tools/solutions.
Experience with Commercial Off the Shelf (COTS) PV systems (ARGUS, ArisGlobal, Veeva, etc).
Ability to articulate complex safety-related business needs in the context of IS systems design, architecture, and development.
Business awareness of wider IS developments within AZ or the pharmaceutical industry, particularly in relation to the design and deployment of safety data sources, solutions, and systems.
Excellent interpersonal skills to influence others to reach agreement/alignment.
Experience in working across different geographic locations, organizations, and cultures to drive vendor and customer relationship management.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we thrive in our dynamic and diverse environment. As part of a global research-led enterprise, there's always novel science to bring to market. We are provided with all the support and tools needed and the agility to move fast. Unleash your ambition and your true self in our inclusive environment where there's opportunity for global mobility, continuous learning, and building best practices.
Ready to make a difference? Apply now!
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.