Job Title Scientist Clinical Trial Safety Global Career Level C Introduction to role Are you ready to make a difference in the world of clinical trials At AstraZeneca the Trial Safety Review Center TRISARC is at the forefront of ensuring patient safety and data accuracy The primary remit of the TRISARC is to review large amounts of clinical mainly safety data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and or clinical project scientists to interpret medical safety data efficiently The Scientist Clinical Trial Safety will work closely with the Senior Scientists Senior Analysts and Associate Director Scientists Clinical Trial Safety to support them in reviewing key and pre-specified medical mainly safety data in clinical trials as operated under the Research and Development R D division of AstraZeneca During the recruitment and maintenance phases of the clinical trial he she uses the Center s data review tools to support review and query important clinical safety data within the scope agreed with medical team and documented accordingly The Scientist also supports preparation facilitation of the meetings and management of study documents and trackers relevant to TRISARC activities Accountabilities Supporting Senior Scientist Senior Analyst and Associate Director Scientist in their activities during study start-up activities by generating managing the documents according to applicable procedures best practices set up configuration of applicable tools review of patient-level clinical safety data on an ongoing basis to ensure medical accuracy and completeness coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure schedule and facilitate different types of meetings creating visualizations from applicable tools and prepare slides reports data as required perform quality check of documents and file TRISARC documents in eTMF Other activities Take on tasks as assigned by the PTS TRISARC LT Provide input into non-drug project work including continuous improvement and development of procedures as needed Update study statuses in tracker with studies per Therapeutic area upon request Ensure TRISARC platforms e g SharePoint contains up-to-date information documents files Coordinate updates if needed TRISARC mailboxes oversight support preparation participate in different type of study meetings e g SSPR meetings Update keep up to date TRISARC distribution lists on ongoing basis Essential Skills Experience Educational degree BSc Msc PhD in Life Science or equivalent work experience in directly related fields preferably medicine pharmacy veterinary biotechnology nurse dentist Knowledge of ICH GCP Guidelines Knowledge of SAE reporting requirements Strong attention-to-detail analytical skills and ability to concisely summarize large amounts of complex information Ability to multi-task in a high-volume environment with shifting priorities Excellent time management Team player able to work individually Computer proficiency Excellent knowledge of spoken and written English Exhibit of AZ Values and Behaviours Desirable Skills Experience Pharmacovigilance background or experience working on clinical studies and or study safety methodology Clinical medical background with practical experience in reviewing SAEs and other safety events Understanding of the clinical study and drug development process Understanding of clinical data flow Programming experience Key relationships to reach solutions Internal to AZ or team Internal Teams TRISARC LT TRISARC Scientists peers and colleagues Partners from collaborating departments Study Physicians Clinical Scientists and their line managers Data Management Centralised Monitoring Study Management Site Management and Monitoring External to AZ Interns Vendors and Suppliers 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 three 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 At AstraZeneca we are driven by our passion for science and innovation Our commitment to exploring new frontiers in healthcare allows us to tackle some of the world s most complex diseases By fusing data and technology with scientific breakthroughs we aim to make a significant impact on patients lives globally Our inclusive environment encourages collaboration across diverse teams fostering an atmosphere where curiosity thrives With opportunities for lifelong learning and career development AstraZeneca is where you can truly make a difference Ready to embark on this exciting journey with us Apply now to join our team and help shape the future of healthcare