Join to apply for the Medical Reviewer/Safety Reviewer III role at Planet Pharma . Get AI-powered advice on this job and more exclusive features. Job Description The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is high-profile and high-impact, working with PPS functions on various product initiatives. As a team member, you will collaborate with leaders to identify priorities and drive projects that impact patient safety. Responsibilities Assist with ongoing continuous improvement projects across departments. Handle individual and periodic medical device safety reporting. Manage PI site notifications. Support training and automation efforts. Provide medical safety consultation on risk/benefit and product safety usage. Understand risk management regulations and standards for medical devices and combination products. Qualifications Biomedical engineer or RN required. Proficient in Microsoft Office, data analysis, research, automation, and case processing of device SAE/AEs, complaints, and SADE cases. Knowledge of R&D, regulatory guidelines (e.g., ICH, GCP, CFR, EU-MDR). Clinical trial and device experience. Familiarity with electronic databases (e.g., Rave EDC, Veeva, Oracle, Salesforce). Strong communication, multi-tasking, and problem-solving skills. Bachelor of Science in Nursing with active RN licensure. Additional Information Pay range: $34-44/hr, depending on experience. Employment: Full-time, with a focus on health care provision. We are an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr Planet Pharma
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