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.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!!
The role is part of the Global Patient Safety organisation and an active member of the Global Market Patient Safety Leadership Team. The successful candidate will lead the strategy, development and delivery of Patient Safety activities across a given region and work closely with cross functional colleagues at a country, regional and global level to ensure that we can accommodate our growing pipeline and meet internal and external partner needs. They will understand trends and developments in both Patient Safety and the wider business and use this insight to ensure a robust and efficient safety model.
Key Responsibilities:
For given region, develop, support and drive excellence in pre-submission and post-approval pharmacovigilance activities related to AstraZeneca and Alexion products.
Primary point of safety contact for the Region and maintains an effective governance structure to ensure oversight of safety activities. This includes requirements outlined in safety data exchange agreements
For given Region drives local input into Patient Safety risk management activities and ensures these are implemented and tracked appropriately.
Supports the development of team members and the broader safety organisation
Supports local market and Commercial SET GVP audits and inspections.
Ensure strong relationships with country safety leads in order to maximise opportunities for Patient Safety and AZ/Alexion products
Act as deputy for the local safety manager, supporting activities under their responsibility and providing cover as required.
Ensures identification and assessment of risks related to regional pharmacovigilance activities and communicates and raises risks to Global Patient Safety and cross functional colleagues as appropriate.
Ensures there is business continuity for Patient Safety activities within the region.
Responsible for ensuring CAPAs related to safety activities in the Region are appropriate to the issue concerned and closed on time
Maintains a thorough understanding of global and local PV requirements that relate to the local safety officer role
Completes assigned training and maintains personal training records
Promotes and implements continuous improvement activities to optimize productivity and quality
Perform oversight of marketing activities to ensure any solicitation/collection of PV information (e.g. in market research programs; clinical study or registry; internet sites; social media) meets AstraZeneca standards and processes and conforms to the terms of a PVA/SDEA with a third party
Maintains a high degree of understanding and awareness on new Patient Safety trends and developments
Requirements:
Science degree or equivalent healthcare professional qualification
Significant experience working in Patient Safety within one or more countries
Experienced knowledge of patient safety regulations and the expectations of Regulatory Authorities.
Desirables:
Experienced reputation within the business and industry
Experience working in Patient Safety in an above-country role
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.
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