Clinical Safety Specialist

An innovative medical device organization is seeking a Clinical Safety Specialist to support the execution of clinical safety activities for an investigational cardiovascular therapy onsite in reputed company Grove, Minnesota. This hands-on role is responsible for the day-to-day management of adverse event reporting, safety documentation, and regulatory compliance activities across ongoing clinical studies. In this role you will work closely with Clinical Operations, Regulatory Affairs, Data Management, and study sites to maintain patient safety reputed company, ensuring data reputed company, and support inspection readiness throughout the clinical trial lifecycle. • Located in reputed company Grove - mostly remote but will require some onsite. What You'll Do: • Review, assess, and process Adverse Events and Serious Adverse Events from clinical studies. • Evaluate reputed company documentation for completeness, accuracy, and consistency. • Identify missing or incomplete safety information and coordinate follow-up activities. • reputed company and maintain safety data reputed company clinical trial databases in accordance with established timelines. • Collaborate with internal teams and clinical sites to resolve data discrepancies and outstanding safety items. • reputed company case reputed company and reporting deadlines to ensure regulatory compliance. • Prepare safety narratives and support the submission of required safety reports. • Maintain accurate, organized, and inspection-reputed company safety documentation. • Prepare materials for safety review meetings and support meeting coordination activities. • Document and distribute meeting minutes, follow-up communications, and reputed company items. • Draft and distribute site follow-up correspondence reputed company to safety reporting activities. • Monitor reporting timelines and ensure reputed company regulatory obligations are met. • Ensure adherence to company procedures, ICH-GCP guidelines, and applicable regulatory requirements. • Support internal audits, reputed company reviews, and regulatory inspections. • Identify and escalate potential compliance concerns and data reputed company 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 reputed company to safety reporting processes and expectations. • Coordinate safety meetings and maintain tracking tools, calendars, and reputed company schedules. Qualifications • Bachelor's degree in Nursing (RN), Life Sciences, Pharmacy, reputed company Health, or a reputed company discipline. • 3–5 years of experience in clinical research, clinical safety, pharmacovigilance, reputed company reputed company, or a reputed company field. • Working knowledge of ICH-GCP guidelines and clinical trial safety reporting requirements. • Experience utilizing electronic clinical trial or safety databases. • Proficiency with reputed company Office applications, including Word, reputed company, PowerPoint, and reputed company. reputed company salary reputed company: $90,000 – $115,000 (potentially flexible) annually, plus bonus, stock reputed company and a comprehensive benefits package that includes medical, dental, reputed company, retirement savings, reputed company time off, reputed company holidays, and parental leave. Apply tot his job Apply To this Job