Associate Director, Patient Safety Scientist Digital & Devices

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Associate Director, Patient Safety Scientist 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.

Business area

The Associate Director, Patient Safety Scientist Digital & Devices is a member of the Patient Safety Digital Health and Device Team and an essential part of the enterprise Device and Digital development team, working collaboratively in the clinical aspects supporting a device and/or digital programmes. The role sits in the Patient Safety Center Of Excellence under the Chief Medical Office.

The Associate Director, Patient Safety Scientist Digital & Devices role includes but is not limited to the shared responsibility with device and digital development team members to review, analyse, and interpret safety data. The Digital & Device Patient Safety Scientist authors and provides patient safety input to safety documents, regulatory reports and leads internal or external meetings to present safety data and analyses. Finally, the Patient Safety Scientist Digital & Devices collaborates on the generation of positions statements related to digital health to support regulatory interactions.

What you’ll do

• Provide patient safety subject matter expertise in digital health & medical devices and across multiple products
  
  

• Provide clinical input to the device and/or digital program’s design and development
  
  

• Contribute to development of clinical device and/or digital documents in collaboration with the Patient Safety Associate Physician - Digital and Devices
  
  

• Review, analyse and interpret safety data obtained to support device and digital development in collaboration with the Patient Safety Physician Digital & Devices
  
  

• Perform duties as Medical Device Surveillance Leader for complex and/or multiple products.
  
  

  • Take accountability and lead resolution of safety issues and mediate cross-functional agreement related to assigned medical devices or digital assets.
    
    

• Provide expertise to the Patient Safety component of contracts/agreements with third parties to ensure the quality and integrity of agreements.
  
  

• Participate in due diligence activities.
  
  

• Participate in cross-functional process improvement or other initiatives related to digital and devices on behalf of the Patient Safety organisation.
  
  

• 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
  
  

• Support individual PS TA’s project/product teams with their implementation and use of digital and devices in association with their assigned AZ medicinal project/product
  
  

• Responsible for the Patient Safety Device, Digital and Diagnostic SharePoint site, including contribution and delivery to consultation requests
  
  

Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements

Essential for the role

• University degree or equivalent qualification in a relevant scientific discipline, with relevant experience (pharmaceutical, regulatory, safety, pharmacovigilance, digital health)
  
  

  • 3 years, Bachelor
    
    

  • 2 years, Post Graduate
    
    

• At least three year’s professional experience in patient safety, regulatory affairs or in quality management systems relating to medical devices1, device constituents and/or digital health
  
  

• Knowledge and understanding of global regulatory, pharmacovigilance, medical device and digital health requirements and an ability to balance this with industry standards to achieve business goals
  
  

• Excellent written and verbal English
  
  

• Leadership experience, either as a line manager or project leader
  
  

• Experience in outsourcing and partnership with external vendors
  
  

• Ability to manage multiple stakeholders
  
  

• Extensive knowledge in project management skills, specifically leading teams
  
  

• Demonstrated excellent skills in written and verbal communication
  
  

• Able to work with a high degree of autonomy
  
  

• Able to represent AstraZeneca externally where required
  
  

Why AstraZeneca

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 is always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next

• 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.

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

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