Location: Mississauga, Barcelona, or Sweden (hybrid 3 days/week in office)At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.Do you have expertise in, and passion for drug safety and real-world evidence (RWE)? Would you like to apply your expertise to evaluate the safety of medicines in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you\xe2\x80\x99re our kind of person.Why AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we\xe2\x80\x99re opening new ways to work, pioneering cutting edge methods, and bringing unexpected teams together. Interested? Come and join our journey. Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t wait to hear from you.The Pharmacoepidemiologist is a scientifically-driven vital position, accountable for driving scientific and operational aspects of post-authorisation safety studies (PASS) and post-marketing commitments/requirements (PMCs/PMRs) utilising RWE, including the use of large electronic healthcare data (EHR) to support various pharmacovigilance and regulatory activities.The incumbent will be responsible for developing and/or leading global strategy and deliverables across various products in the AZ Biopharmaceuticals portfolio and will also support and coordinate with local markets on mandated PASS requiring local RWE data. They will work closely with cross-functional internal stakeholders across Global Patient Safety, Global Regulatory, Global/Local Medical, and R&D to develop strategic plans for using epidemiological tools and methods. They will also ensure studies are designed and implemented in accordance with the regulatory requirements in anticipation of requests from EMA, FDA, and other regulatory agencies. The incumbent will provide scientific guidance and direction for pharmacoepidemiology, collaborating with colleagues and peers from a wide variety of disciplines to ensure optimal management of relevant studies.In addition, the pharmacoepidemiologist would have responsibilities over conducting rapid healthcare analytics using large electronic healthcare data using R or through an in-house analytical platform, for the purpose of supporting drug development and/or responding to healthcare authority (e.g., FDA, EMA, etc) requests.The Pharmacoepidemiologist must be able toProvide strong, detailed guidance for optimizing pharmacoepidemiology and pharmacovigilance study design and executionDevelop design and drafting of protocols and a broad range of observational research including primary data collection and secondary use of dataConduct ad hoc literature reviews on Patient Safety related RWE and related mattersLeverage large electronic healthcare data to conduct rapid healthcare analytics, using a consultative and problem-solving approach, working under tight deadlines with imperfect informationEssential RequirementsPh.D. or equivalent in pharmacoepidemiology, epidemiology or related health science field with substantial experience analysing large electronic healthcare data.Strong background in epidemiological theory and methods, including appropriate use of medical statistics to solving problems in epidemiologyConceptual understanding of secondary data and/or primary data collection studies to design and conduct post-authorisation safety studiesAble to provide a robust literature review and perform critical appraisals to published studiesAbility to work effectively with colleagues from a wide variety of disciplinesDesirable RequirementsPrior work experience as a pharmacoepidemiologist or quantitative epidemiologistAbility to work independently to achieve specific research objectivesExperience planning, analysing and interpreting results of statistical analyses performed using large electronic healthcare dataA solutions-oriented approach to using imperfect data, coming up with pragmatic ways forward to reach research objectivesAbility to work under pressure to generate results quickly to support health authority requests and/or insights needed to further clinical developmentWorking knowledge of epidemiological methods used in research in drug development or in a closely related academic research areaGreat People want to Work with us! Find out why:Are you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .Date Posted 20-Mar-2024Closing Date 19-Mar-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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