Epidemiologist - Patient Safety (Remote, US)

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Epidemiologist - Patient Safety (Remote, US)

We are seeking an Epidemiologist - Patient Safety for a global pharmaceutical client. You will be responsible for providing assistance in Epidemiology's role to support the cross-functional Safety Management Teams (SMT). You will be expected to work on post-marketing requirements (PMR/PAS) as well as assist in the signal detection and management processes.

This is a 40-hour per-week, 6-month contract (extensions possible), 100% Remote role in the US.

Work Schedule: Mon Fri 8:00am to 5:00pm.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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.

Requirements:

  • 5+ years of experience with the following:

  • Experience in observational study design

  • Experience working with regulatory submissions to health authorities

  • Experience with data analysis - SAS/R

  • Experience working in a leading role within a metrics team

  • Master's Degree or PhD is must have.

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Epidemiologist - Patient Safety (Remote, US) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $66.93/hr. - $89.24/hr. (Depending on location)

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