Senior Manager, Safety Scientist

This is what you will do:   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.  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 plans and contributing to REMS documents  Assisting GPS Medical Directors in the development of risk management strategy  Training and/or leading junior safety scientists and fellows  Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels  Assisting Global Safety Physicians in developing a strategy for safety-related regulatory activities  Proactively leading safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines Supporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templates   Representing global patient safety as a subject matter authority in clinical study teams and cross-functional meetings  Contributing to initiatives for process improvement and cross-departmental process consistency  Maintaining a strong, up-to-date solid understanding of evolving global regulations    Required skills and experience: Bachelor’s degree in a biologic/medical/clinical/nursing field with at least 3 years of experience in drug safety/pharmacovigilance  Knowledge of global pharmacovigilance regulations  Strong analytical and problem-solving skills  Excellent communication and interpersonal skills  Strong scientific writing skills  Demonstrated learning agility and ability to work independently  Good judgement   Ability to interact effectively with people of multiple subject areas and cultures both within and outside the company on a global basis  Basic understanding of downstream regulatory, patient, business, and reputational impact of PV actions  The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.  Desirable skills: Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD Experience preparing aggregate safety reports and conducting signal surveillance  Experience with clinical development including risk/benefit analysis and safety assessment  Expertise with clinical and safety databases  Experience in MedDRA coding and search strategies  Strong personal time-management and project-management skills  Experience with data visualization tools (e.g., Power BI, Spotfire)  Project leadership, organizational, and prioritization skills  When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The annual base pay for this position ranges from $132,873 to $199,310. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer o