At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
As a Scientist for Patient Safety Sciences, Analytics and Systems, you will be leading change through innovation. This role accountable for understanding and translating business needs into business requirements to address future information and systems solutions in support of vital PS Systems capabilities
Provides global knowledge for product, process, and database knowledge to ensure safety information is optimally evaluated in the most efficient manner while remaining aligned with strategic direction across the business.
Manages applicable tools and methodologies to ensure existing processes and systems fully address the needs of the collaborators.
Finds opportunities where innovative solutions and continuous improvement plans should be better aligned with standard methodology across the industry.
Evaluates new modules and software upgrades and assesses the impact on system validation, the user community and standardized processes related to PS Systems.
Retains a global perspective of the business need for accurate information and systems resources, while maintaining a focus on regulatory and corporate compliance needs; requires the foresight to anticipate business, regulatory and wider industry trends, and apply these in the development of safety solutions.
Collaborates closely across the Patient Safety Center of Excellence (PS CoE) organization, with partners, IT vendors, and other specialists involved in the design, development and delivery of information and analytics solutions.
Handling user support arrangements (e.g. training, helpdesk) and making sure Service Level Agreements are in place for systems with R&D IT and /or other partners.
Demonstrate detailed knowledge of statistical methods, inclusive of empirical Bayesian disproportional algorithms, in order to support AstraZeneca in detection of trends in safety signals.
Utilize data visualization and reporting tools to ensure end-user evaluation of safety data is on-target and analyzed accurately independent of output.
BS in a scientific field
Meaningful experience in supporting safety-related activities in the area of clinical biopharmaceutical development.
3+ years Patient Safety or similar pharmaceutical industry experience, preferably with extensive involvement in the successful design, delivery or deployment of information/systems solutions in support of safety or PV-related work.
Experience in safety signal management, data visualization and reporting tools, and/or the exploitation of data used to define the safety profile.
Advanced degree in a clinical or safety subject area.
5+ years in pharmacovigilance with demonstrated record of supporting tools / solutions to address safety information in conjunction with IT.
Significant experience in system validation, audit and PV inspection activities and requirements.