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This role is a project-based consulting opportunity to conduct medical reviewing on an as-needed basis.
This is not a full-time position.
Roles & Responsibilities Provide medical expertise on development-related or emerging cardiac safety concerns Responsible for medical monitoring tasks Provide medical input throughout the development process Provide medical input into the development and execution of study documents and plans, such as study protocol, IB, SMP, DMP, SAP, Lab manuals, etc.
Provide significant expertise as primary medical reviewer of individual adverse event reports, clinical, and safety documents Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations Responsible for strategies in monitoring and analysis of cumulative safety information Maintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reporting Job Requirements Medical degree required (MD or equivalent) Specialty in Cardiology or comparable experience in Cardiology 5 or more years of clinical experience and/ or research experience required Relevant experience in medical monitoring and/or medical reviewer in pharmaceutical industry Excellent scientific writing skills Ability to understand clinical data Proficiency with MS Office applications Good communication skills Strong knowledge of current regulatory practices and domestic and international regulations Powered by JazzHR
Cardiology Medical Reviewer (Project-Based) - Remote • Boston, MA, US
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