Cardiology Medical Reviewer (Project-Based) - Remote
Remote · United States
Job Summary
Project-based Cardiology Medical Reviewer role focusing on cardiac safety in development programs. Provide medical expertise on development-related cardiac safety concerns and medical monitoring tasks; offer input throughout study documentation (protocol, IB, SMP, DMP, SAP, Lab manuals) and act as primary medical reviewer for individual adverse event reports and safety documents. Lead safety activities for assigned products, contribute to pre- and post-marketing risk management strategies, stay current with pharmacovigilance methods and regulatory guidance, and monitor analysis of cumulative safety information while maintaining knowledge of global and local regulations relevant to medical review and safety reporting.
Required Qualifications
- 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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