Associate Director, Patient Safety Digital & Devices

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Associate Director, Patient Safety Digital & Devices

Do you have expertise in, and passion for, Patient Safety? Would you like to apply your expertise to impact the Device & Digital team in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.

The Associate Director, Patient Safety Digital & Devices is a member of the Patient Safety Digital Health and Devices Team. The role sits in the Patient Safety Center Of Excellence under the Chief Medical Office.

The Associate Director, Patient Safety Digital & Devices responsibilities include but is not limited to the management of device, digital and diagnostic processes and partnerships. This includes the implementation, communication, compliance, performance and inspection readiness within Patient Safety. In addition to this, the unique responsibility of providing Patient Safety’s input enterprise wide processes and projects related to devices, digital and diagnostics. Finally, collaborating on the generation of positions statements related to digital health to support regulatory interactions.

What you’ll do

• Responsible for the management of Patient Safety procedures related to devices, digital and diagnostic including process creation, implementation, communication, performance and inspection readiness
• Ensure that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant stakeholders to improve processes.
• For the processes assigned, responsible for ensuring compliance with medical device, including device constituents, safety and performance global regulations and health authority requirements
• Lead and/or contribute to the generation of Patient Safety’s position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities
• Project manage projects to agreed targets and provide expert operational / strategic input and guidance (regulatory, pharmacovigilance and patient safety) to cross-functional teams
• Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes, deliveries and partnerships.
• Manage relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s Patient Safety & Pharmacovigilance license to operate responsibilities
• Contribute to the overall management and oversight of the Patient Safety Quality System
• Responsible for the Patient Safety Device, Digital and Diagnostic SharePoint site, including contribution and delivery to consultation requests
• Build relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities, including successful partnerships
• Participate and /or support activities for GVP, GCP, GRP and GMP audits/inspections
• Partner with License Agreement & Contracts where medical devices, device constituents, digital health or diagnostics are involved
• Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement of processes, technology and services within the Patient Safety Device, Digital and Diagnostic area that they lead.
• Partner with Patient Safety Systems counterparts to ensure an integrated and holistic approach to processes and systems.
• For the assigned medical device or digital health projects, represents PS on cross-functional project teams for developmental and/or marketed medical devices and digital health products.
• Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements
• Serve as the delegate, where appropriate, for the Process Lead and deputy for the Patient Safety Person Responsible for Regulatory Compliance
  
  

• University degree or equivalent qualification in relevant scientific discipline, with relevant experience (pharmaceutical, regulatory, safety, pharmacovigilance, digital health)
  • 3 years, Bachelor
  • 2 years, Post Graduate
• At least one year’s professional experience in patient safety, regulatory affairs or in quality management systems relating to medical devices1 and device constituents
• Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals
• Experience from authoring standards documents (Standard Operating procedures)
• Ability to manage multiple stakeholders
• Knowledge in project management skills, specifically leading teams
• Demonstrated excellent skills in: written and verbal communication
• Able to work with high degree of autonomy
  
  

At AstraZeneca, we ’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.