Pharmacoepidemiologist

Job Title: Pharmacoepidemiologist Location: Lawrenceville, NJ (Remote) Duration: 06 Months Pay Rate: $68.21 - $87.48/ hr on W2 Work Schedule: Mon - Fri 9:00 am to 5:00pm Top 3 to 5 Skills/Must Haves: • experience in observational study design • working with regulatory submissions to health authorities • Data analysis - SAS/R • working in a leading role within a metrics team Job Description: Purpose and Scope of the Position: We are seeking a highly motivated epidemiologist to be part of the Patient Safety organization. The successful candidate will be responsible for providing assistance in Epidemiology role to support the cross-functional Safety Management Teams (SMT). She/he will be expected to work on post-marketing requirements (PMR/PAS) as well as assist in the signal detection and management processes. Duties and Responsibilities: • Managing post-marketing studies (PMR/PAS) in the execution and reporting phases. • Participating in planning and preparing strategic regulatory aggregate reports (e.g. Risk Management Plan, Periodic Benefit-Risk Evaluation Report, Product Label Updates). • Supporting Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional Medical Surveillance Teams (SMTs) and assigned sub-teams, such as Safety Data Review (SDR) Teams. • Participating in the development of materials regarding issues impacting key SMT activities, milestones, or documents. • Executing searches of the worldwide literature and other data sources, applying critical thinking and independent research skills to ensure the information is appropriate and usable. • Assisting in safety surveillance and signal detection for products across therapeutic areas. • Leading, planning, organizing, and forecasting requirements and/or resources based on Book of Work and other upcoming tasks and activities for assigned product portfolio. • Executing searches of the corporate safety database, J-review database, and the worldwide literature, applying critical thinking and independent research skills to ensure the information is appropriate and usable. • Applying medical, life science and general scientific knowledge and expertise to create and manage plans and budgets for designated projects. Education: • Masters Degree in Related Field(s) plus 5+ years of experience OR • PhD with 3 years of experience Experience: • Experience in observational study design. • Experience working with regulatory submissions to heath authorities. • Data Analysis using SAS/R. • Working in a leading role within a metrics team. Working Conditions: • No exposure to hazards or disagreeable conditions. The starting hourly compensation for this assignment is within the range of $68.21 - $87.48/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not the Client). Factors influencing this decision ma include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.