Are you excited about Patient Safety?
Would you like to have an impact on patients' lives and contribute to eliminating cancer as a cause of death?
If so, then join us!
About AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization 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 areaWe 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.
What you'll doThe 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 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, analyze, 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 organization.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 QualificationsA 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.Desired requirementsExperience of working in a global organization, 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.Why AstraZenecaAt AstraZeneca we're dedicated to being a Great Place to Work.
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