Associate Director, Patient Safety Scientist Digital & Devices

Are you excited about Patient Safety? Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!!

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Business area

The Associate Director, Patient Safety Scientist Digital & Devices is a member of the Patient Safety Digital Health and Devices Team. The role sits in the Patient Safety Centre Of Excellence.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

What you’ll do

The Associate Director, Patient Safety Scientist Digital & Devices role includes the shared responsibility with device and digital development team members to review, analyse, and interpret safety data. They author and provide patient safety input to safety documents, regulatory reports and lead internal and external meetings to present safety data and analyses. Finally, they collaborate on the generation of positions statements related to digital health to support regulatory interactions. Duties include:

  • Provide 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

  • 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 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 organisation.

  • 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

Required Experience, Skills, and Qualifications

  • University degree or equivalent qualification in relevant scientific field, with experience (pharmaceutical, regulatory, safety, pharmacovigilance, digital health) – 3 years, Bachelor/2 years, Post Graduate

  • At least three years 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

  • Experience of leadership of team, either as line manager or project leader

  • Experience in outsourcing and partnership with external vendors

  • Ability to lead multiple partners

  • Able to work with high degree of autonomy

Desired requirements

  • PhD in scientific field

  • Knowledge of new and developing regulatory and pharmacovigilance expectations

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 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 envisioning yourself joining our team? Good, because we can’t wait to hear from you.

Closing date: Friday 25th February 2022

Competitive salary and benefits package on offer.

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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