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Arbetsbeskrivning
Do you have knowledge in regulatory/pharmacovigilance and partnership issues ? Do you have a "can do" attitude and a innovative approach and want to contribute to ensure good relationships across Patient Safety and center of Excellence within Astra Zeneca? Then this unique role with a broad spectrum of responsibilities might be the one for you!
At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Ensuring AstraZeneca comply with Pharmacovigilance regulations is key and in our team we make sure to make this 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.
We are now looking for you who wants to join our Global PV Processes, Partnerships and Contracts group in Patient Safety Centre of Excellence, CMO. We are responsible for the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, compliance, performance and inspection readiness within Pharmacovigilance. We ensure good relationships across Patient Safety and Centre of Excellence in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.
What you'll do
As Pharmacovigilance Process & Partnership Principal you will work in close collaboration with the Pharmacovigilance Process and Partnership leads and Patient Safety and Regulatory experts to develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting. You will use your knowledge to identify opportunities for and drive the enhancement of existing processes and partnerships through knowledge of internal and external environment by utilizing safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
Other responsibilities in this position:
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Manage relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca's pharmacovigilance and regulatory License to operate responsibilities.
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Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches
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Contribute to the overall management and oversight of the Pharmacovigilance Quality System.
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Coordination and ownership of the lifecycle management of nominated processes and partnerships, enabling business continuity and compliance and identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
With this in mind we believe that you have a teamworking attitude and that your excellent written and verbal communication skills prove your ability to work across cultures.
Essential for the role
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A science/pharmacy/nursing degree, with relevant experience (pharmaceutical, regulatory, safety and partnership)
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Experience in working cross-functionally
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Leadership skills, including proven leadership of project teams experience
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Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
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Thorough knowledge of the drug development process
Desirable for the role
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Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
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Knowledge of new and developing regulatory and pharmacovigilance expectations
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Knowledge of existing AstraZeneca external alliances and collaborative projects
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Knowledge of CoE and CMO operating model
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Experience of working with third party suppliers
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
We are screening applications continuously so please apply as soon as possible but no later than December 16th, 2020.
Where can I find out more?
Our Social Media:
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
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