What You'll Do: Review, assess, and process Adverse Events and Serious Adverse Events from clinical studies. Evaluate source documentation for completeness, accuracy, and consistency. Identify missing or incomplete safety information and coordinate follow-up activities. Enter and maintain safety data within clinical trial databases in accordance with established timelines. Collaborate with internal teams and clinical sites to resolve data discrepancies and outstanding safety items. Track case progress and reporting deadlines to ensure regulatory compliance. Prepare safety narratives and support the submission of required safety reports. Maintain accurate, organized, and inspection-ready safety documentation. Prepare materials for safety review meetings and support meeting coordination activities. Document and distribute meeting minutes, follow-up communications, and action items. Draft and distribute site follow-up correspondence related to safety reporting activities. Monitor reporting timelines and ensure all regulatory obligations are met. Ensure adherence to company procedures, ICH-GCP guidelines, and applicable regulatory requirements. Support internal audits, quality reviews, and regulatory inspections. Identify and elevate potential compliance concerns and data quality issues. Contribute to process improvements that enhance safety operations and compliance effectiveness. Partner closely with Clinical Operations, Regulatory Affairs, Data Management, and other cross-functional teams. Communicate proactively regarding case status, timelines, and emerging issues. Assist with training and education related to safety reporting processes and expectations. Coordinate safety meetings and maintain tracking tools, calendars, and milestone schedules. Qualifications Bachelor's degree in Nursing (RN), Life Sciences, Pharmacy, Public Health, or a related discipline. 3-5 years of experience in clinical research, clinical safety, pharmacovigilance, healthcare quality, or a related field. Working knowledge of ICH-GCP guidelines and clinical trial safety reporting requirements. Experience utilizing electronic clinical trial or safety databases. Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook. Base salary range: $90,000 - $115,000 (potentially flexible) annually, plus bonus, stock options and a comprehensive benefits package that includes medical, dental, vision, retirement savings, paid time off, paid holidays, and parental leave. #J-18808-Ljbffr
Clinical Safety Specialist • Maple Grove, MN, United States
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