Cardiology Medical Reviewer (Project-Based) - Remote
- 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
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