Overview

Position is at the University of Pennsylvania Perelman School of Medicine

The individual’s primary functions will be to manage and lead aspects of pharmacoepidemiologic studies, including but not limited to: a) understanding and interpreting data arising from observational research studies of medical products, managing and cataloging data output/findings, tracking the conduct of statistical analyses described in observational research protocols and accompanying analytic plans, analyzing data, and drafting manuscripts; b) leading biomedical literature (i.e., systematic and scoping) reviews and synthesizing findings; c) completing institutional review board applications; d) completing data use agreement, data reuse agreement, and business associate agreement applications, and liaising with external groups (e.g., the Centers for Medicare and Medicaid Services) to execute these agreements; e) designing medical record abstraction forms and abstracting clinical data from primary medical records; f) managing conflict of interest reporting and data retention requirements; g) drafting research plan (e.g., data description, sample size) and technical sections of grant applications (e.g., protection of human subjects, inclusion of women, children, and minorities, research facilities and equipment), study abstracts, and manuscripts; h) drafting study progress reports; and i) generating data from publicly-available health statistics datasets (e.g., the Centers for Disease Control and Prevention’s National Center for Health Statistics).

The individual will have secondary functions. These include: a) managing the Center for Real-World Effectiveness and Safety of Therapeutics’ (CREST’s) UPenn-Food and Drug Administration (FDA) certificate program in pharmacoepidemiology (including liaising with FDA); and b) support CREST activities, including but not limited to managing its online presence. The latter requires a basic understanding of health communication and social media platforms.

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Qualifications

Masters’ degree is required and 3 to 5 years of experience or equivalent combination of education and experience is required. MPH degree is strongly preferred. Some training in epidemiology is strongly preferred. Minimum of three (3) years of experience in project management is required.
Prior experience in managing pharmacoepidemiology or real-world evidence studies is strongly preferred.
Intermediate understanding of research in medicine is required. Intermediate understanding of non-experimental/observational research designs is required. Intermediate understanding of prescription drugs is strongly preferred.
Intermediate understanding of healthcare claims and electronic medical record data is strongly preferred. Intermediate understanding of Centers for Medicare and Medicaid Services (CMS), Optum, and Marketscan data structures is preferred.
Experience in conducting biomedical literature and/or scoping reviews is required. Experience in managing in-person and remote certificate-level educational programs is preferred.
Experience in drafting sections of federal grant applications is preferred.
Experience in drafting applications to institutional review boards is strongly preferred. Advanced understanding of research ethics and HIPAA protections is strongly preferred.
Experience in executing data use agreements with CMS is preferred.
Experience in manipulating and generating summary data from publicly available health datasets is preferred.
This position requires an individual that is highly organized and self-motivated with an ability to multi-task and pay attention to detail.
This position requires an individual with excellent written skills and excellent verbal skills, including comfort presenting in group settings.
This position requires a dedicated individual that values collaboration and works well in a team.
This position requires proficiency in Microsoft Office software, database management system software (e.g., Microsoft Access, REDCap), reference manager software (e.g., RefWorks), project management software, prescription drug software (e.g., Lexicon Plus). Proficiency in at least one programming software language (i.e., SQL, R, SAS, SPSS, or Stata) is preferred.
Position contingent upon continued funding.

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