Associate Director, Patient Safety Scientist Digital & Devices (12 Months FTC)
Location: Cheshire East, Luton
Job Type: Full time
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!!
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.
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 Centre 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!
What you’ll do
The Digital & Device Patient Safety Scientist is an important part of the Device and Digital development team, working collaboratively and cross functionally (in a matrix environment) with other members. The Digital & Device Patient Safety Scientist works collaboratively in the clinical aspects underpinning a device and/or digital program and supports products through their lifecycle.
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. 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
A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
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
Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
Thorough knowledge of the drug development process
Good attention to detail
Excellent written and verbal communication skills
Shown ability to work across cultures
Experience of 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 working with third party suppliers.
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.
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.
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.