Ophthalmology Medical Monitor/SME (Project-Based) - Remote
- 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 medical expertise to sponsors in the drug development process
- 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 medical monitoring tasks, which may include:
- Eligibility review
- Review of safety-related protocol‑related deviations
- Review of safety data
- Develop Medical Monitor Plan
- Participation in medical monitoring and/or safety review meetings as needed
- Medical management of queries
- Medical coding review
- Maintain records and logs
- Medical review of study documents
- 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 Ophthalmology or comparable experience in Ophthalmology
- 5 or more years of clinical experience and/ or research experience required
- Relevant experience in safety physician, safety committee membership, 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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