Associate Director, PV Processes and Partnerships

Do you have knowledge in regulatory requirements in pharmacovigilance and experience in working in partnership relations ? Do you have a "can do" attitude and an 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. Ensuring AstraZeneca comply with Pharmacovigilance regulations is key and in our team we make sure to make this a reality.

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 as an Associate Director.

We are responsible for the management of assigned AstraZeneca processes, projects 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 an Associate Director you will be working with the Processes and Partnership Director, taking responsibility for the management of assigned AstraZeneca processes, projects and partnerships including implementation, communication, compliance, performance and inspection readiness for ICSR management and/or Signal Detection. You will be accountable to develop relationships across Patient Safety 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.

Here you will have a great opportunity to use your deep understanding of pharmacovigilance processes and regulations providing process or compliance support to safety deliverables as well as to develop and maintain a vision and strategy for nominated pharmacovigilance processes. In addition you will:

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Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment
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Working with the PV P, P&C Directors and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting
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Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy
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Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca's pharmacovigilance and regulatory LTO responsibilities
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Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment
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Working with the PV P, P&C Directors , and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting
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Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy
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Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca's pharmacovigilance and regulatory LTO responsibilities
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Provide support to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection

We are looking for you that have a proven ability to work across cultures using your strong negotiation, conflict management and interpersonal skills to influence whilst maintaining an independent and objective view.

Essential for the role

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A science/pharmacy/nursing degree, with at least 5 years 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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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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Experience of working with third party suppliers

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.

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 29th, 2022.