Medical Physician Specialist I

You will be providing medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. Your responsibilities will include conducting primary medical review of cases, assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review. Daily case data update and documentation, along with feedback in appropriate trackers/tools, will be essential for efficient tracking and workflow management. It will be your responsibility to ensure the quality, compliance, and productivity of all assigned deliverables within the expected SLAs and KPIs. After a tenure of 1 year, you will provide training and guidance to the case processing team on medical aspects of case processing. Additionally, you will perform aggregate and signal analysis activities to support single case processing and maintain a culture of high customer service. Qualifications: - Bachelor's degree in medical science, MD, DO, or equivalent degree. - Relevant experience may be considered in lieu of educational requirements. - Language proficiency in English at ILR level 3+ for speaking and ILR level 4+ for writing/reading. Experience: - Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and procedures. - Understanding of regulatory requirements for Clinical Research. - Familiarity with ICH-GCP guidelines. Preferred Qualifications: - 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment: - Work may be in an office or home-based environment as requested by the line manager. For more information on our Equal Employment Opportunity (EEO) and Accommodations request, please refer to our website.,