The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework. You will be responsible for: Managing safety scientist activities across multiple product portfolios and/or indications Organizing, training and/or supporting junior safety scientists and fellows Supporting activities related to new drug applications and other regulatory filings Representing global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy Representing GPS in global program teams and associated cross functional teams and/or projects as needed Proactively providing guidance and educational training to GPS therapeutic teams Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors Performing Signal Surveillance activities for respective programs in collaboration with GPS Medical Directors Project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical Directors Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists GPS Medical Directors in the development of risk management strategy and activities for assigned products Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates Assisting GPS Medical Directors to oversee risk minimization activities including tracking of activities as needed May be directed by the line function to support initiatives outside of their projects You must have: Bachelor's degree in a biologic/medical/clinical/nursing field At least 5 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry Knowledge and understanding of US and EU safety regulations pre- and post- marketing

Experience

with Risk Management and Minimization programs

Experience

preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans

Experience

with clinical development including risk/benefit analysis and safety assessment Strong clinical, analytical, problem solving and scientific writing and communication skills Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis Expertise with Microsoft Word, PowerPoint, SharePoint and Excel 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 Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Knowledge of Power BI, and other visualization tools The annual base pay ranges from $126,000 to $190,000. 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 05-Aug-2026 Closing Date 18-Aug-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.