Business Quality Manager, Associate Director PV Systems

Is the interface between technical and business domains in pharmacovigilance an area where you thrive and deliver insights and value? Would you like to apply your expertise in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

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 a reality. 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.

The vision of the AstraZeneca Patient Safety Centre of Excellence 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
We are looking for a Business Quality Manager to join us in the Patient Safety System team. We are a global team of experts and project managers who manage and support the technical systems (safety database and associated systems) involved in handling, tracking and analysing adverse events data. If you become one of us, you will work across organisational and geographical borders as an expert in quality management to ensure our systems remain compliant with internal and external requirements as they evolve. We will also be looking to you to help build frameworks and approaches for implementing novel capabilities such as artificial intelligence and machine learning in our highly regulated context.

As a Business Quality Manager (Associate Director Patient Safety Systems), you

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work in the interface between business and technical teams, ensuring the systems meet internal and external requirements
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ensure documentation relating to system and system releases meets internal standards and procedures
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identify approaches for validating innovative solutions, including machine-learning and other novel automation
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ensure the quality of business-related content of relevant improvement project proposals and associated documentation
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support audits and inspections by providing expert advice on computer system validation processes

Essential for the role

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At least bachelor's degree in a scientific field
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Experience of computer system validation in a regulated environment
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Broad knowledge of drug development process, including an understanding of clinical trials, regulatory safety obligations and pharmacovigilance practices
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Good understanding of system development lifecycle methodologies
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Experience in approaches for determining, reaching and maintaining acceptable quality levels

Desirable for the role

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Higher degree in a clinical or safety-related field
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Significant experience (5+ years) in pharmacovigilance with proven record of supporting tools/solutions to address safety information in conjunction with IT
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Business awareness of wider IT developments within pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions and systems
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Excellent interpersonal skills to influence/shape your particular area of expertise
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Experience in working across different geographic locations, organisations, and cultures to drive vendor and customer relationship management

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 March 16, 2022.