Our client, a leading pharmaceutical company, is hiring a Pharmacoepidemiologist, on a contract basis.
Job ID: 83368
Work Location:
100% Remote role
Summary:
Seeking a highly motivated epidemiologist to be part of the Patient Safety organization. The successful candidate will be responsible for providing assistance in Epidemiology’s 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.
Education/Experience:
- Masters Degree in Related Field(s) plus 5 years of experience OR PhD with 3 years of 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.
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.
Pay:
- Southeast $65-66/hour
- Northeast $73-75/hour
- West $86-88/hour