The Associate Director, Safety Scientist plays a pivotal role within Global Patient Safety, providing strategic leadership and project management to proactively evaluate and manage safety risks in close collaboration with GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). You will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures. You will report to the Director, Safety Scientist, GPS and be based in Boston, MA. You will be responsible for: Leading 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 Leading the 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 Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA) Mentoring, training and/or managing 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 managing 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 expert 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 working knowledge of evolving global regulations You will have: Bachelor’s degree in a biologic/medical/clinical/nursing field At least 5+ year experience in pharmaceutical industry in drug safety/pharmacovigilance Subject matter expertise in global pharmacovigilance regulations Experience preparing aggregate safety reports and conducting signal surveillance Experience with clinical development including risk/benefit analysis and safety assessment Strong analytical and problem-solving skills Excellent communication and interpersonal skills Strong scientific writing skills Demonstrated learning agility and ability to work independently Ability to apply decision-making principles to contribute to key scientific/clinical discussions Sound, independent judgement based on knowledge and expertise Ability to interact effectively with colleagues of multiple disciplines and cultures both within and outside the company on a global basis Understanding of the 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. Nice to have: Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD 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) Advanced project leadership with strong organizational and prioritization skills Experience with various roles in drug safety (e.g., case processing, operations) Mastery of Microsoft Word, PowerPoint and Excel The annual base pay ranges from $126K to $190K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 21-Oct-2026 Closing Date 03-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

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