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Job ID296093BRPosition TitleSenior Expert EpidemiologistApply to Job
80! That’s the number of Novartis products that the Quantitative Safety & Epidemiology (QSE) team is responsible for. QSE is an interdisciplinary group in the global Patient Safety organization; 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 scientific methods.
As Senior Expert Epidemiologist you will influence and drive the epidemiology strategy of one or several drugs within a therapeutic area during the whole life cycle including drug development, regulatory submissions and health authority requests pre- and post-submission.
You will discuss with senior management (e.g. Patient Safety Leadership Team, Global Program Heads, Franchise Heads), influence the strategic decisions on most appropriate epidemiology data sources, study designs and analysis methods, and contextualize information from epidemiology and other data sources by using quantitative methods and data visualizations.
Your responsibilities will include:
• Lead the epidemiology strategy of a drug during the whole life cycle including drug development, regulatory submissions and health authority requests pre- and post-submission for one or several drugs within a therapeutic area.
• Influence and drive implementation of modern and innovative epidemiology approaches to robustly evaluate the safety and ultimately the benefit-risk profile of a drug based on data from different sources (e.g., literature, non-interventional and interventional studies) in a pro-active manner.
• Represent Epidemiology in the Safety Management Team. Work in close collaboration with the Quantitative Safety Scientist, the Global Project Safety Lead and other team members of the Safety Management Team (e.g. Clinical Lead, Regulatory Lead, Lead Statistician).
• Design, conduct, analyze, interpret and report simple and complex epidemiological studies using databases such as CPRD and MarketScan. Have the scientific oversight and management of non-interventional studies if outsourced.
• Are responsible for the epidemiological sections of documents for the Health Authorities, including but not restricted to product submissions, Health Authority requests, RMPs, Safety Update reports, Labeling documents, Safety Profiling Plans, RiskMAPs, and Expert Statements. Put epidemiology information into context of information from other data sources.
• Generate systematic reviews using best practice methodologies to evaluate published evidence, and provide commentaries on manuscripts and publications of epidemiological studies of importance to Novartis.
• Drive, lead and implement improvement initiatives. Promote awareness and use of epidemiological expertise within Novartis and interact with epidemiology professionals in academia, industry and regulatory agencies as the recognized Novartis pharmaco-epidemiology expert.
What you’ll bring to the role:
• Master’s degree or comparable in epidemiology, statistics, health services research or related areas (PhD preferred)
• Fluent English (oral and written)
• 10+ years of experience in positions of increasing responsibility in the Pharmaceutical Industry with 6+ years expert knowledge and substantial experience of epidemiological principles and methodologies and its application to drug development and life cycle management.
• Proven experience in leading global scientific improvement/ change initiatives / direct reports. Excellent strategic skills. Natural modern leadership style building partnerships and collaborative environments.
• Strong experience in matrix management and strong interpersonal and communication skills (verbal and writing) bridging scientific and business needs over different expertise areas – integrating epidemiology, quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence and/or leading teams through the gap identification, developing and implementing processes, methods, standards and tools.
• Computing ability, including knowledge of specialized epidemiological/statistical packages (advanced level, SAS or R experience desirable). Experience in designing, conducting, analyzing and interpreting epidemiological studies and working with large electronic health records databases.
• Solid knowledge of drug development and HA guidelines, especially as relevant to epidemiological methods.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkDivisionGlobal Drug DevelopmentBusiness UnitCMO & PATIENT SAFETY GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
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