Junior Assistant Medical Manager - Safety Nurse

<p><b><span class="emphasis-2">Job Overview:</span></b></p><p>Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.</p><ul></ul><p></p><p><b><span class="emphasis-2">Summary of Responsibilities:</span></b></p><ul><li>Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review.</li><li>Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.</li><li>Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.</li><li>Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year.</li><li>Performs aggregate and signal analysis activities, as required in support of single case processing.</li><li>Creates, maintains, and assumes accountability for a culture of high customer service.</li></ul><p></p><p><b><span class="emphasis-2">Qualifications (Minimum Required):</span></b></p><ul><li>Bachelor’s degree in Nursing.</li><li>Preferrably with 2 years clinical experience</li><li>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li><li>Language Skills: Speaking: English at ILR level 3&#43; or higher.</li><li>Writing / Reading: English at ILR level 4&#43; or higher.</li></ul><p></p><p><b><span class="emphasis-2">Experience (Minimum Required):</span></b></p><ul><li>Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures.</li><li>Knowledge and understanding of regulatory requirements for Clinical Research.</li><li>Knowledge and understanding of ICH-GCP guidelines.</li></ul><p></p><p><b><span class="emphasis-2">Preferred Qualifications Include:</span></b></p><ul><li>2 years of Clinical practice experience or 2 years PV experience</li></ul><p></p><p><b><span class="emphasis-2">Physical Demands/Work Environment:</span></b></p><ul><li>Office or home-based environment, as requested by the line manager.</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>