Associate Director, Patient Safety Device & Digital
Job Type: Full time
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.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!!
The Associate Director, Patient Safety Device & Digital leads the Patient Safety Device, Digital and Diagnostic process area. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office
The Associate Director, Patient Safety Processes & Partnerships responsibilities includes but is not limited to providing leadership to the device, digital and diagnostic process area including implementation, communication, compliance, performance and inspection readiness within Patient Safety and Pharmacovigilance.
Responsible for the lifecycle management assigned Patient Safety processes related to devices, digital and diagnostic
Demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/partner engagement.
Support the oversight of medical device, digital health and in-vitro diagnostic regulations and local requirements that impact Patient Safety and/or require implementation
Serve as the delegate, where appropriate, for the Director, Device & Digital Safety
Support the allocation of and contribution to digital, device and diagnostic consultation requests of Patient Safety
Partner with License Agreement & Contracts where medical devices, digital health or diagnostics are involved
Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.
Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant partners to improve processes.
Accountable for being a great partner with supplier(s) providing all external services to the group as appropriate.
Partner with system counterparts to ensure an integrated and holistic approach to processes and systems.
Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers
Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance
Participate in projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross-functional teams.
In partnership with peers (Other Nominated Area Leads) establish, champion and facilitate a top tier partnership relationship with the outsource provider. Includes championing relationship with internal AZ partners and forging strong partnership with all customers/partners. Ensures that all internal and external relationships and interfaces are handled effectively.
Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements
University degree or equivalent qualification in relevant scientific field, with relevant experience
two years, Post Graduate
three years, Bachelors
At least two 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 design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role.
Experience from authoring standards documents (Standard Operating procedures)
Experience from development and provision of training through virtual meetings and other media
Experience in outsourcing and partnership with external vendors
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
Understanding of governance processes
Process improvement (e.g. Lean methodology)
Ability to influence without authority
Open to multiple perspectives
Experience with inspection activities
University degree or equivalent qualification in relevant scientific field, with at least five years relevant experience
PhD in scientific field
Knowledge of new and developing regulatory and pharmacovigilance expectations
Experience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745)
*** We will be reviewing applications and shortlisting on a rolling basis - as such we reserve the right to withdraw this vacancy ahead of the stated closing date
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.