.At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.We do this with integrity even in the most difficult situations because we are committed to doing the right thing.Patient Safety at AstraZeneca is now looking for an experienced Senior Patient Safety Scientist to join our Patient Safety BioPharma team in Warsaw Poland. The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the marketAs a Senior Patient Safety (PS) Scientist, you will work collaboratively with other PS Scientist(s) and Physicians. You will play a role supporting the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.In this exciting and challenging role, you will provide leadership in aggregating, reviewing, analyzing and interpreting safety data to generate information to support safety decision-making by prescribers, patients, health authorities and payers, with the ultimate goal of protecting patients. You will apply your strong pharmacovigilance, therapeutic area and scientific experience, knowledge and skills to lead in all aspects of safety documentation, including authoring and / or providing strategic safety input to regulatory documents, e.G., regulatory reports, health authority responses and the safety content of marketing authorization applications. You evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.Main ResponsibilitiesLeads 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.Leads the collaboration with Global Safety Physician (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