Precision for Medicineis the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as aPrincipal Safety Specialist? Position Summary: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.Essential functions of the job include but are not limited to: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 systemsParticipate in the assessment and set-up of a safety database to capture SAE dataPerform 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 proceduresQC of documents and safety reportsPreparation and/or review of project specific safety reporting plans and medical coding plansPreparation and/or review of safety training materialsDevelop and manage standard operating procedures and work instructionsServe as subject matter expert for departmentProvide ongoing training and mentorship for Safety SpecialistsParticipate in audits and audit preparation, kick-off meetings, and investigator meetingsParticipate in bid defenses for existing and potential clientsAssist departmental management with resource managementAssist departmental management with oversightServe as project manager for safety standalone projectsLead departmental initiatives and cross-functional development activitiesAssist clients and/or other departmental staff with safety-related reviews and other servicesQualifications:Minimum Required:BA/BS degree10+ years clinical safety experience Other Required:Health care professionalHands on experience with global safety database(s), SAE case processing, and safety reports generationWorking knowledge of MedDRA and WHODrugWorking knowledge of FDA safety regulations, ICH guidelines, and global safety regulationsPreferred:Nursing or pharmacy degreeIndustry experience in CRO or pharmaceutical company
