Primary Location:  Basel, Switzerland

Alternate Location(s): Dublin, Ireland  / Barcelona, Spain / London Westworks, United Kingdom

Working model:  All locations have a hybrid working model (12 days per month in the office)

Note: Novartis is not able to offer relocation or visa support for this role. Please only apply if the location is accessible for you and you have the right to work in the country you are applying to.

Major accountabilities:

On program and project level:

• Influences and drives epidemiology strategy for drug programs during the full life cycle with growing independence.
• Core member of the Safety Management team; collaborates with medical safety, clinical, regulatory, and other scientists for quantitative decision-making.
• Ensures timeliness and quality of epidemiology deliverables.
• Builds partnerships with external database holders and researchers.
• Proposes and implements modern epidemiology approaches to evaluate drug safety and benefit-risk profile.
• Responsible for epidemiological sections of documents for health authorities.
• Puts epidemiology information into context with other data sources.
• Plans, prioritizes, and oversees project-level activities and resource management.
• Drives adherence to organizational standards and regulatory guidelines.
• Represents the QSE line function at internal decision boards and contributes to health authority responses.

On study level:

• Provides epidemiology support to safety management teams with a focus on quantitative contextualization of safety data.
• Contributes to epidemiological strategy for critical non-interventional studies.
• Maintains knowledge and expertise in epidemiological data sources suitable for addressing safety issues and study populations.

On enterprise and external level:

• Actively contributes to cross-functional improvement initiatives.
• Promotes the use of RWE and innovative methods through scientific collaborations, publications, and presentations.
• Proposes improvement initiatives within QSE and across departments to support company objectives.

Role Requirements

Education & Work Experience:

• Master’s degree in epidemiology, statistics, health services research or comparable with 6+ years relevant work experience

or

• PhD in epidemiology, statistics, health services research or comparable with 4+ years relevant work experience

Skills:

• Proven and strong knowledge and experience in designing, conducting, analyzing and interpreting epidemiological studies
• Strong knowledge of epidemiology and statistical methods and their application to safety signals, safety risk assessments and benefit-risk assessments.
• Experience of working with large electronic health records databases.
• Ability to critically appraise and synthesize epidemiological literature.
• Computing ability, including knowledge of specialized epidemiological/statistical packages (advanced level, SAS or R experience desirable).
• Hands-on experience in contributing to the interface to regulatory agencies.

Languages:

• Fluent English both spoken and written.

Closing date for applications: 08 October 2024