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Associate Director Pharmacovigilance Processes

AstraZeneca UK

Location: Cambridgeshire, Cheshire East, Gaithersburg, Maryland

Job Type: Full time


Be brave, not perfect.
- Reshma Saujani

Do you have knowledge in regulatory requirements in pharmacovigilance and experience in working with process planning and management? Do you have a “can do” attitude and an innovative approach and want to contribute to ensure high quality process management and support across Patient Safety 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.

To meet our business priorities and address resource demands, 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 Pharmacovigilance Processes Manager, Associate Director and Director, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. You will be accountable to develop relationships across Patient Safety and other relevant areas of AZ to execute the delivery of the processes strategy, priorities, alongside governance and management of the current procedural documents.

Here you will be able to use your ability to build relationships working closely with stakeholders and customers, supporting pharmacovigilance and regulatory activities and responsibilities including successful partnerships. A big part in being successful in this position is to working collaboratively providing expertise and sharing best practices across all regions and in all partnerships. In addition you will:

  • Identify opportunities for and drive the enhancement of existing processes through knowledge of internal and external environment

  • Lead the management of process updates in Patient Safety; initiate updates, project manage the delivery of a new document, work with the BPO for content updates, address comments, release the document

  • Be an expert in the ECMS tool and associated processes

  • Support PS Process owners with guidance, advice and support on PD process.

  • Contribute to the overall management and oversight of the Pharmacovigilance Quality System

  • Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation

  • Provide process training to relevant functional groups

With this in mind, we are looking for you that have a proven ability to work across cultures using your strong negotiation, conflict management and interpersonal skills.

Essential for the role

  • A science/pharmacy/nursing degree, with previous relevant experience (pharmaceutical, regulatory, safety and partnership)

  • Experience in working cross-functionally

  • Leadership skills, including proven leadership of project teams experience

  • Good attention to detail

  • Knowledge of AZ Business and processes

  • Able to influence whilst maintaining independent and objective view

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!

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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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.