Job Description

Job Description Pay range: 34-44/hr *depending on experience 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 a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. Activities performed under this team: Assisting with ongoing continuous improvement projects spanning across departmental needs Responsible for individual and periodic medical device safety reporting Responsible for PI site notifications Providing support for training and automation efforts Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Biomedical engineer or RN Required Experience & Skills: Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting) Clinical Trial Experience Clinical Trial Device Experience Knowledge of electronic databases (e.g., Rave EDC, Veeva EDC, Microsoft Office including Excel, Oracle, Veeva, Salesforce Applications and other database tools) Ability to effectively interact with and influence others without direct reporting relationships Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs Ability to Meet Challenging Milestones with results orientation - Skilled Strategic Decision Making and Negotiation - Skilled Facilitating Change and managing conflicts - Skilled Ability to Problem Solve Independently & with Others - Highly Skilled Business Organization & Industry Awareness - Highly Skilled Cross Functional Relationships and communication skills - Highly Skilled Execution / Results / Process Improvement - Highly Skilled Background / Required and Preferred Education Level Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing RN Required (Active licensure) The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma. Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available. Planet Pharma

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