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Advisor/Sr Advisor- Pharmacoepidemiology

Purpose:

The purpose of the Global Patient Safety Pharmacoepidemiology Scientist (GPS PE) is to provide pharmacoepidemiology leadership and technical support to the GPS Organization, Business Unit (BU) Teams, Value, Evidence and Outcomes (VEO), Affiliates, and other functional areas within the Company. As part of a cross-functional team, the GPS PE will have the following responsibilities: support the development and execution of risk management plans; identify and evaluate potential safety signals and address safety questions from regulators. The GPS PE will have primary responsibility for designing and conducting pharmacoepidemiology studies using appropriate methods and data sources; for understanding the natural history of targeted health conditions; and for collaborating with external research organizations. The GPS PE role may also entail some in-line or project-level supervisory responsibilities

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Global Patient Safety Support

• Demonstrate knowledge of relevant global regulatory requirements and practices; act as subject matter expert in the development and maintenance of procedures and required tools in the quality system as they relate to epidemiology; provide pharmacoepidemiology support to GPS Surveillance Teams; demonstrate understanding of the roles and responsibility of the EU QPPV; support audit readiness; provide epidemiological expertise as it relates to signal detection and signal management for the portfolio

Support Risk Management Planning Provide epidemiology expertise to support compounds in development, submission activities (including Post Authorisation Safety Study (PASS), new product launches, and existing marketed products; partner/collaborate with both BU Teams and GPS Medical Physician/CRS on the development of risk management plans. Contribute to the Risk Management Strategy/RWE Safety Strategy for a molecule. Design/execution/interpretation of pharmacoepidemiology studies including design and review of study protocols, SAPs, final study reports, presentations and manuscripts. Lead the conduct of the pharmacoepidemiology studies internally (when appropriate) and collaborate/contract with external investigators and CROs as needed; provide scientific expertise in interpretation and communication of results of pharmacoepidemiology studies; contribute to the design/execution/interpretation Risk Minimisation Evaluation Surveys and REMS; Characterize Natural History of Diseases

• Provide support to BU Teams and GPS Physician/CRS with patient population data from the literature or other relevant data sources to understand the nature and burden of illness of various disease/conditions for which the Company is developing new products to treat or to prevent; Including support of Orphan Drug Applications (ODA), Pediatric Investigation Plans (PIP), and Pediatric Study Plans (PSP). Conduct and manage epidemiology studies to characterize disease trends, frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors and treatments

Collaboration with Internal and External Customers

• Communicate effectively with relevant internal business partners; collaborate with BU Teams and Regulatory Scientists as part of issue management teams and in preparation of responses to requests posed by regulatory authorities; support BU Teams regarding safety information requests and other safety activities; collaborate with external partners and participate on key external initiatives.

Strategic Development of Analytic Tools

• Develop analytic tools to support activities such as disease state characterization, signal detection, clarification, and evaluation utilizing multiple data sources (e.g., spontaneous, health claims and electronic health records); partner on the development of new standardized analytic methods for selected regulatory safety documents/submissions (e.g., PBRER/PSUR, ISS, product labels).

Supervisory Responsibilities

• The role may also entail line supervisory or contract-employee responsibilities for a small group of Epidemiologists, including implementation of organizational objectives, putting in place and ensuring execution of performance management and development plans, performance assessment, coaching, addressing human resource related issues, providing scientific guidance and project oversight, ensuring compliance with SOPs and regulations, implementation of functional coordination/standardization across projects, and building staff capacity or optimizing productivity. The supervisory responsibilities may require up to 25-30% of the epidemiologist’s time; the remaining 70-75% will focus on direct portfolio support and technical/scientific activities.

Additional Responsibilities for Sr Director

Monitor, Interpret and Influence the External Environment Regarding Pharmacoepidemiology and Drug Safety

• Represent Lilly, and/or, coordinate Lilly representation, on specific external epidemiology/drug safety groups to respond to the external environment. Know what is developing and ongoing at the FDA and EMEA, as it relates to epidemiology. Leverage external contacts for scientific competitive intelligence through informal and formal benchmarking projects and related forums.

Collaboration with Internal and External Partners

• Communicate effectively with relevant internal business partners; provide epidemiology training to GPS and Business Unit (BU) Teams; collaborate with BU Teams, Regulatory Scientists, other internal partners and external partners on key epidemiology, drug safety and select safety communication initiatives

Minimum Qualification Requirements:

• A PhD or DrPH in epidemiology.
• Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans.
• Competent in the independent analysis of data and interpretation of results from clinical and epidemiology studies.
• Excellent computer skills; knowledge of statistical software packages to analyze epidemiological data
• Have strong analytic skills, oral and written communication skills, strong interpersonal and leadership skills, and able to work independently and as a team member to resolve a variety of drug safety issues.

Other Information/Additional Preferences:

• Clinical background (e.g., PharmD, MD, RN)
• Experience conducting epidemiological studies
• High-level knowledge of global regulations with respect to drug safety and adverse event reporting
• High-level knowledge and good understanding of GPS policies
• Ability to learn and apply technical knowledge to meet changing project needs.
• Flexibility and ability to prioritize work to meet interpersonal and scientific goals.
• Ability to balance multiple activities, prioritize and handle ambiguity

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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