Cardiology Medical Reviewer; Project Remote

This role is a project-based consulting opportunity to conduct medical reviewing on an as‑needed basis. This is not a full‑time position.

• 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

• 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