<p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">As our company continues we grow we are seeking a <strong>Safety Specialist/Safety Lead </strong>to join our growing team.</span></p> <p><span style="font-size: 10pt;">Position Summary:</span><br><span style="font-size: 10pt;">Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.</span><br><span style="font-size: 10pt;">Essential functions of the job include but are not limited to:</span><br><span style="font-size: 10pt;">• Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.</span><br><span style="font-size: 10pt;">• Participate in the assessment and set-up of a safety database to capture SAE data.</span><br><span style="font-size: 10pt;">• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.</span><br><span style="font-size: 10pt;">• QC of documents and safety reports.</span><br><span style="font-size: 10pt;">• Preparation and/or review of project-specific safety reporting plans and medical coding plans.</span><br><span style="font-size: 10pt;">• Preparation and/or review of safety training materials.</span><br><span style="font-size: 10pt;">• Provide safety training and oversight for consultants, contractors and/or staff.</span><br><span style="font-size: 10pt;">• Review and/or draft standard operating procedures and work instructions.</span><br><span style="font-size: 10pt;">• Assist clients and/or other departmental staff with safety-related reviews and other services.</span><br><span style="font-size: 10pt;">• Other duties as assigned.</span></p> <p><span style="font-size: 10pt;">Requirement:</span><br><span style="font-size: 10pt;">• BA/BS degree</span><br><span style="font-size: 10pt;">• Minimum 5 years safety experience</span></p> <p><br><span style="font-size: 10pt;">Other Required:</span><br><span style="font-size: 10pt;">• Health care professional</span><br><span style="font-size: 10pt;">• Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation</span><br><span style="font-size: 10pt;">• Working knowledge of MedDRA and WHODrug</span><br><span style="font-size: 10pt;">• Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.</span><br><span style="font-size: 10pt;">Preferred:</span><br><span style="font-size: 10pt;">• Nursing or pharmacy degree preferred</span><br><span style="font-size: 10pt;">• Clinical trial safety experience</span><br><span style="font-size: 10pt;">• Hands on experience with Argus</span><br><span style="font-size: 10pt;">• Industry experience in CRO or pharmaceutical company preferred</span></p><div class="content-conclusion"><hr> <p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0">Privacy Policy.</a> For CA applicants, please also refer to our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0">CA Privacy Notice</a>.</p> <p>Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p> <p>If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use t