Manager Patient Safety Systems

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible possible. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

We are now looking for a Manager Patient Safety Systems to our PS Systems Team. As part of Patient Safety we are accountable for managing the information assets and systems ensuring they are effectively governed and enhanced to meet PS' scientific, business and compliance needs.

The vision of our unit, a part of the broader AstraZeneca Patient Safety organisation, is to pursue functional excellence for Patient Safety across the business by providing specialised expertise in Safety Science, Pharmacovigilance and Risk Management, while optimising Safety Processes, Systems, Policy, Compliance and Governance.

What you'll do
In this position you will have specific responsibility for ensuring the technical evolution of AZ's Surveillance systems and platforms throughout their lifecycle. You provide technical guidance on the development of strategic plans for PS surveillance systems as well as evaluate new modules and software upgrades and assess the impact on system validation, the user community and PV processes. Additionally, in this role you will be responsible for ensuring that all change is conducted in line with applicable standards and that system enhancements are driven by value to the business and thus generate efficiencies or promote the advancement of safety insights.

More specifically, as a Manager for Patient Safety (Surveillance) Systems, you will

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manage applicable tools and methodologies to ensure processes and systems fully address the needs of stakeholders
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ensure that the system is changed in an effective and timely manner to meet new health authority requirements and / or changed business demands (e.g. divestment, in-licensing, partnership etc.)
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provide user support arrangements (e.g. training, helpdesk support)
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support the ongoing business utilization of PS systems, including troubleshooting problems and developing solutions
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contribute to the development of procedures, work instructions, system specifications, primarily related to the use of PS Systems and related PS owned information sources and toolsets.
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ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures.
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be accountable for the collective quality, efficiency and timely completion of activities.

With this in mind the role requires mature communication and interpersonal skills with an ability to work across and within cross-functional teams, at the interface between Business and IT and in partnership with external vendors/partners.

Essential for the role

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Bachelor's degree in a scientific or technical discipline with relevant experience in life sciences
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Significant experience in technology and supporting/maintaining/evolving regulated application and tools.
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Broad knowledge of the safety information tools required to support drug development and marketed brands including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices
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Ability to articulate complex safety-related business needs in the context of patient safety systems design, architecture and development
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Business awareness of wider information systems development within the pharmaceutical industry, particularly in relation to the design and deployment of safety data sources, solutions and surveillance systems
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Significant experience in computer system validation

Desirable for the role

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Higher degree in a clinical, safety, technology or business related discipline
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Able to identify opportunities to lead change through continuous improvement
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Experience of working in safety-related roles across multiple therapeutic or business areas within other biopharmaceutical, regulatory or health organizations
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Experience of developing training materials and providing training
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Experience of audit and inspection activities and requirements for GxP systems
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Project Management experience and/or background required for overseeing and coordinating implementations of new systems or system upgrades

Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?

Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organisational goals!

So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We welcome you with your application, no later than 1st of June, 2022.