Advisor/Sr Advisor - Pharmacoepidemiology
Full time
at eli lilly and company
in
Ireland
Posted on May 8, 2024
Job details
Advisor/Sr Advisor - Pharmacoepidemiology page is loaded
Advisor/Sr Advisor - Pharmacoepidemiology
Apply locations Ireland, Cork time type Full time posted on Posted Yesterday job requisition id R-63073 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. 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
- 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
- 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.
- 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).
- 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.
- 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.
- 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
- 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.
- 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
About Us
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!#J-18808-LjbffrApply safely
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