Associate Director, Patient Safety Physician 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

We are looking for a new member of the Device, Digital & Diagnostics Team within the Pharmacovigilance (PV) Processes, Partnerships and Contracts Team within the Patient Safety Center of Excellence. You will be working on the assigned AstraZeneca medical device & digital health projects as well as the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology and services within the area of devices & digital. This work ensures compliance with applicable industry regulations and AstraZeneca Global and Local Policies.

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

The Digital & Device Patient Safety Associate Physician is the lead medical/clinical member and an important part of the Device and Digital development team, working collaboratively and cross functionally (in a matrix environment). In addition, provides medical/clinical input to device and/or digital programs to support device and digital programmes through the lifecycle from development to post-marketing.

We ensure good relationships across Patient Safety, Therapeutic Areas and Centre of Excellence in CMO, R&D Digital, Device Development, On-Market Device Operations and other relevant areas of AZ to implement the delivery of the projects, processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.

What you’ll do

  • Provide medical and clinical input to medical device, device constituent and digital health projects, including but not limited to implementation impact assessments, risk management activities, clinical evaluation, post-market surveillance and post-market vigilance

  • Drive the evaluation of the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources

  • Provide medical and clinical insight in the review, analysis and interpretation of safety data and lead internal and external meetings to present safety data and analyses

  • Providing authoring and patient safety input to safety documents and regulatory reports

  • Represent Patient Safety 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

  • Support the Patient Safety Therapetic Areas in the implementation of medical devices and digital health into medicinal product development and post market activities

Required Experience, Skills, and Qualifications

  • Medical degree (eg MD, MBBS) with at least 2 years of clinical experience post-registration

  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals

  • Experience with combination products (Drug+Device), Digital Health and/or Medical Devices

  • Experience with contributing to digital or device development documents, such as medical device hazard assessments

  • Experience in working cross-functionally

  • Leadership skills, including shown leadership of project teams experience

  • Detailed scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues

  • Detailed knowledge of the drug development process

Desired requirements

  • Experience working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry

  • Knowledge of new and developing regulatory and pharmacovigilance expectations

  • Knowledge of existing AstraZeneca external alliances and collaborative projects

  • Knowledge of CoE and CMO operating model

  • Experience of working with third party suppliers

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: 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.

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.

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