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Director/Senior Director Epidemiologist (345223BR)


Executive Director



East Hanover, New Jersey, United States

80! The Quantitative Safety & Epidemiology team is responsible for 80 Novartis products! We are an interdisciplinary group in the global Patient Safety organization, and we help regulators, physicians, and patients to understand the benefits and risks of assigned drugs, by asking the right questions and by applying the most appropriate non-interventional scientific methods. <br>As Director Epidemiologist you will drive and implement the safety epidemiology strategy for a program with multiple indications or several programs of the same or similar indications during the full life cycle including early and full development, pre-, peri- and post-regulatory submissions. <br>Responsibilities will include but are not limited to: <br>• Proposes and implements modern and innovative epidemiology approaches in the designing, carrying out and reporting epidemiological studies using real-world databases and providing the scientific oversight for other non-interventional studies, to robustly evaluate the safety and ultimately the benefit-risk profile of a drug. <br>• Expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy) for complex, critical non-interventional studies across programs/indications <br>• Leading collaborations and effective partnerships with medical safety, epidemiology, clinical, regulatory and quantitative scientists to ensure benefit-risk decision-making based on data from different sources in a pro-active manner <br>• Proposing and implementing improvement initiatives internally and externally in collaboration with epidemiology professionals in academia, industry and regulatory agencies <br>• Representing Quantitative Safety & Epidemiology at internal and external decision boards <br>• Mentoring others in developing safety epidemiology strategy<br><br>[#video#{#400,300#}#/video#]