Quantitative Safety & Epidemiology is an interdisciplinary group in the global Patient Safety organization which provides high quality scientific contributions to safety management teams to support decision making in all phases of the drug life-
cycle by evaluating safety data and benefit-risk
As a Senior Epidemiologist, you will represent epidemiology in the Safety Management Teams of one or several drugs. You will lead the discussion and 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 data sources.
Major Accountabilities :
1. Develops, implements and monitors epidemiology and risk management strategy of one or several drugs.
2. Leads the discussion and 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 literature and non-interventional studies in a pro-active manner.
3. Represents Epidemiology in the Safety Management Team. Works in close collaboration with the Quantitative Safety Scientist, the Brand Safety Leader and other team members of the Safety Management Team (e.
g. GPMD, DRA Lead, Lead Statistician).
4. Designs, conducts, analyzes, interprets and reports simple and complex epidemiological studies using databases such as CPRD and MarketScan.
Has the scientific oversight and management of non-interventional studies if outsourced.
5. Is 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.
Puts epidemiology information into context of information from other data sources.
6. Generates systematic reviews using best practice methodologies to evaluate published evidence, and provide commentaries on manuscripts and publications of epidemiological studies of importance to Novartis.
7. Maintains knowledge / expertise of existing epidemiological data sources which may be suitable to address issues involving safety of products, identification of characteristics of study populations and development of the knowledge of therapeutic areas.
8. Provides epidemiology support to safety management teams with a strong focus on quantitative contextualization of safety data from different data sources.
9. Actively participates in scientific meetings by giving presentations.
10. Drives, leads and implements improvement initiatives within QSE and across departments in support of departmental, divisional, and company objectives.
Master’s degree or comparable in epidemiology, statistics, health services research or related areas (PhD preferred)
Fluent English (oral and written)
Ideal candidate's background :
1) 6+ years of experience in positions with increasing relevant responsibilities in the Pharmaceutical Industry.
2) 4+ years expert knowledge and substantial experience of epidemiological principles and methodologies and its applications to the pharmaceutical industry applied to drug development and life cycle management.
3) Strong interpersonal and communication skills (verbal and writing) bridging scientific and business needs integrating epidemiology, quantitative sciences, strong disease area knowledge and appropriate market / competitive intelligence.
4) Expert scientific leadership skills
5) Computing ability, including knowledge of specialized epidemiological / statistical packages (advanced level, SAS or R experience desirable).
6) Experience in designing, conducting, analyzing and interpreting epidemiological studies.
7) Experience of working with large electronic health records databases.
8) Solid knowledge of drug development and HA guidelines