Pharmacoepidemiologist

Job Description

Job Summary:

• 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’s role to support the cross-functional Safety Management Teams (SMT).
• She/he will be expected to work on post-marketing requirements (PMR/Client) as well as assist in the signal detection and management processes.

Duties and Responsibilities:

• Managing post-marketing studies (PMR/Client) 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:

• Master’s Degree in Related Field(s) plus 5+ years of experience.
  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.