Clinical Application Specialist

Spectraforce Technologies
United States, California, Irvine
Nov 03, 2024
Job Title: Clinical Application Specialist II (not DSS group) Duration: 1 Year (possible extension) Description: The person in this contractor position will provide support to the Global Epidemiology group in Pharmacovigilance & Patient Safety. This person will contribute to the design and execution of pharmacoepidemiologic studies, support characterization of descriptive epidemiology for diseases and indications, contribute to regulatory submissions and responses, and perform literature reviews on topics required for ongoing support and/or development of drugs and devices. Responsibilities: Evaluate, synthesize, and communicate epidemiology literature in both written and presentation formats. Lead or contribute to the development of new evidence through study design, protocol development, and statistical analysis plans of various databases, including secondary data sources, such as administrative claims or health records data. Support departmental need to contribute to and develop content for sections of risk management plans, benefit risk assessments, safety and regulatory deliverables Understands the role of epidemiology in signal evaluation and where epidemiology contributes to key safety and regulatory deliverables Required Experience: PhD/MD/PharmD with experience in the field of epidemiology, outcomes research, or related discipline. Excellent understanding of epidemiologic data sources and methods and a demonstrated ability to apply them to address program needs. Experience with disease epidemiology (population sizing) globally and regionally using short-term studies/analyses. Required Skills: Demonstrated experience in managing studies or projects. Understanding of epidemiology methods and study design. Knowledge of public and private databases including large observational databases. Excellent oral and written communication skills. Strong organizational skills and ability to meet deadlines.