Global Patient Safety Pharmacoepidemiologist

Lilly • Indianapolis, IN

3d • $171,000 - $299,200 • Onsite

About The Position

The Global Patient Safety Pharmacoepidemiologist (GPS PE), reporting into GPS Medical, is responsible for providing scientific and data-driven guidance to meet strategic objectives in generating data to characterize the safety profile of Lilly products. The GPS PE contributes to cross-functional teams responsible for generating primary data or analyzing secondary data sources to assess the benefit-risk profile of Lilly products. This role supports the development and execution of risk management plans, identifies and evaluates potential safety signals, addresses safety questions from regulators, and designs and conducts pharmacoepidemiology studies. The GPS PE role may also involve some in-line or project-level supervisory responsibilities.

Requirements

• PhD in Epidemiology or related Public Health field
• 3+ years of experience in scientific research or the pharmaceutical industry
• High-level knowledge of global regulations with respect to drug safety and adverse event reporting
• Strong analytical skills and ability to apply statistical and epidemiological methodology in research projects
• Understanding of risk management strategies and risk minimization programs
• Competent in the conduct of epidemiology studies
• Competency 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
• Highly effective written and verbal communication skills
• Ability to work on multiple projects and function effectively in a fast-paced matrixed environment
• Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines
• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
• Excellent teamwork skills
• Ability to learn and apply technical knowledge to meet changing project needs
• Experience using longitudinal national databases, claims databases, or electronic medical records (e.g. GPRD) for epidemiologic research
• Strategic thinker with proven project execution and innovation experience

Nice To Haves

• Applying AI-driven programming techniques to enhance pharmacoepidemiologic study design, data analysis, and signal detection activities

Responsibilities

• Collaborates within a cross-functional team and leads the design and execution of observational studies to ensure high quality, scientifically rigorous pharmacoepidemiology study proposals, protocols, statistical analysis plans, clinical study reports, abstracts/publications and/or presentations.
• Contributes to the Risk Management Strategy/Real World Evidence Safety Strategy for assigned molecule(s).
• Designs, coordinates, and implements observational epidemiological studies (including secondary use dataset studies) on epidemiology disease burden, natural history of disease, and assessment of background rates for identified/potential drug risks.
• Develops new methodologies and appropriately utilizes pharmacoepidemiologic tools for the identification and analysis of potential safety signals; applies in-depth epidemiologic methods to address complex research questions.
• Leads the conduct of pharmacoepidemiology studies internally (when appropriate) and collaborates/contracts with external investigators and Third-Party Organizations as needed; provides scientific expertise in interpretation and communication of results of pharmacoepidemiology studies.
• Collaborates on developing strategic 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); partners on the development of new standardized analytic methods for selected regulatory safety documents/submissions (e.g., PBRER/PSUR, ISS, product labels).
• Provides input into regulatory documents such as Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and responses to regulatory queries.
• Provides epidemiological expertise as it relates to signal detection and signal management for the portfolio.
• Collects and analyzes patient population data from literature/other sources to assess disease burden providing support for regulatory submissions (e.g., Orphan Drug Applications, Pediatric Investigation Plans, or Pediatric Study Plans).
• Represents Lilly and coordinates its presence in external epidemiology or drug safety groups.
• Stays updated on regulatory activities (eg, FDA, EMA) related to epidemiology.
• Uses external contacts for scientific intelligence through benchmarking projects and forums.
• Supports strategy across lifecycle through evidence generation.
• Contributes to the Risk Management Strategy/RWE Safety Strategy for a molecule.
• Designs/executes/interprets pharmacoepidemiology studies including design and review of study protocols, SAPs, final study reports, presentations, and manuscripts.
• Leads the conduct of pharmacoepidemiology studies internally (when appropriate) and collaborates/contracts with external investigators and CROs as needed; provides scientific expertise in interpretation and communication of results of pharmacoepidemiology studies.
• Provides training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.
• Maintains compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.
• Maintains compliance with the Lilly Corporate Integrity Agreement.
• Fosters and supports a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery.
• Recruits, mentors, develops, and retains top scientific and drug development talent.
• Assures staff comply with company policies and procedures.
• Understands the roles and responsibilities of the European Union Qualified Person (QPPV).
• Ensures support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree