Address
Form of workPurpose:
Deliver epidemiology content to core safety and regulatory documents including, but not limited to, RMPs, BRPAs, ODAs, Briefing Books, and MSAs. Participates in vendor or collaborator selection, protocol development, questionnaire design, statistical analysis plans.
Responsibilities:
- Independently manages well-defined projects, clearly communicates the results and is an effective member of various teams as necessary. Is able to understand and analyze specific epidemiologic databases and prepare relevant tables and figures.
- Conducts comprehensive literature reviews and summarizes evidence to support signal analysis, establishment of background rates for disease states and support risk management plan development.
- Contributes to design, management and analysis of observational studies, including registries, providing critical appraisal of observational studies and observational study protocols through active participation in inter-departmental and cross-functional committees (as assigned) and in support of PSTs or other product governance bodies.
- Collaborates with Pharmaceutical Development, Medical Affairs, HEOR and Statistics in order to support delivering team goals. Collaborates with Commercial for conversion of sales data to exposure data.
- Functional Competencies: Technical expertise and successful track record: Has a high level of technical expertise in epidemiology and pharmaco-epidemiology methods, databases, and study design and has success in developing and executing epidemiology studies.
- Communication of scientific concepts: Is able to communicate verbally and in writing, epidemiology concepts to diverse audiences. Can articulate study rationale, design and expected impact to supported programs.
- Business acumen: Sufficient and developing knowledge of the businesses; knowledgeable in current and possible future polices, practices, trends, developments in information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
- Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
- Understands methods of adverse event collection and evaluation, individual and aggregate case review, and signal detection and signal validation. Has significant knowledge of quality assurance, legal and regulatory functions as well as knowledge of data base functionalities and management processes. Maintains high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.
Qualifications:
- MPH or MS with more than 7 years of experience or PhD degree with 2 or more years of experience in academia or industry in the field of epidemiology/pharmacoepidemiology, surveillance-related or risk management.
- Preference given to individuals with industry experience
