Introduction: The Associate Director, Senior Patient Safety Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. He/she authors and leads PV input to safety documents and regulatory reports. Associate Director, Senior Patient Safety Scientist leads meetings and presents safety data and analyses. Main Responsibilities: Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate. Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products. Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports. Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects. Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders. Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products. Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements. Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc. Requirements – Education and Experience A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience Advanced knowledge of PV regulations Substantial pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug development, with experience independently delivering safety-science activities. Experience in at least 2 (two)of the following: clinical development safety; signal management; periodic safety reports; safety sections of protocols/IBs/ICFs/CSRs; regulatory responses. Good knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines. MD/MSc/PhD in scientific discipline, preferred Intermediate understanding of epidemiology, preferred Date Posted 05-Nov-2026 Closing Date 30-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.

Associate Director, Senior Patient Safety Scientist.

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