Senior Manager, Safety Scientist

About the role

The Senior Manager, Safety Scientist plays a pivotal role within Global Patient Safety to actively evaluate and manage safety risks in close collaboration with the GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). The individual will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures. At AstraZeneca's Alexion division, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio and an entrepreneurial spirit, you'll be part of a team that values connection and collaboration. We empower our employees through tailored development programs that align personal growth with our mission. Join us in driving change with integrity while celebrating diversity and innovation. Join us in our unique and ambitious world.

Responsibilities

• Contributing to safety data reviews and analyses for products in designated therapeutic areas
• Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
• Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
• Ensuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)
• Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.
• Authoring and project management of health authority queries
• Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management