PbAre you being referred to one of our roles by a connection in Alira Health? /bIf so, please apply using the referral link emailed to you. /ppJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. /ppbJob Description Summary /b /ppbJob Description /b /ph3ROLE /h3pThe Sr. Safety Scientist is an important member of the Alira Health Clinical team. This person provides technical and process-related support to safety management (clinical trial and post-market) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). The Sr. Safety Scientist is responsible for case receipt, processing, data entry, and query resolution, as well as development of project-specific safety procedures, workflows, and templates. The Sr. Safety Scientist has client-facing responsibilities and provides mentoring to team members. The Sr. Safety Scientist should have experience in multiple therapeutic areas and extensive hands-on safety database experience. /ph3KEY RESPONSABILITIES /h3pManages the receipt and processing of all serious adverse event (SAE) and unanticipated adverse device effect (UADE) reports from a clinical trial. /ppPerforms accurate data entry of SAE/UADE information in the safety database and tracking systems (Oracle Argus or ArisGlobal LifeSphere Multivigilance preferred). /ppReviews SAEs/UADEs for completeness, accuracy, and appropriateness for expedited reporting. /ppDrafts safety narratives and Individual Case Summary Reports (ICSRs). /ppCodes adverse events and medical history accurately using MedDRA and codes medications with WHODRUG. /ppDetermines expectedness/ listedness against appropriate label. /ppIdentifies clinically significant information missing from initial reports and ensures its collection. /ppInitiates, tracks, and resolves requests for follow-up information from clinical sites. /ppEnsures all cases receive appropriate medical review. /ppPrepares follow-up correspondence and consults with the medical staff accordingly. /ppEnsures all cases that require expedited reporting are processed swiftly and appropriately within required timelines. /ppProvides QC of adverse event reports for other members of the safety team. /ppAssists in the development of project-specific safety procedures, workflows, and templates. /ppAssists in project-specific safety database set-up, development of data entry guidelines, and user acceptance testing. /ppCreates and maintains project-specific working files. /ppMaintains a strong understanding of safety database conventions. /ppWorks with data management teams on reconciliation of safety data. /ppMonitors workflow for assigned studies and programs to ensure all deadlines are met. /ppAlong with senior pharmacovigilance team members, prepares Medical Monitoring Plans, Safety Plans, Data Migration Plans, and Pharmacovigilance Plans. /ppParticipates in internal, client/sponsor, and other meetings as required. /ppComplies with ICH GCP guidelines, FDA regulations, and company SOPs. /ppManages and resolve conflicting priorities to deliver on commitments. /ppPerforms additional duties as assigned. /ph3DESIRED QUALIFICATION EXPERIENCE /h3pBS/BA from an undergraduate program, registered nurse, or an equivalent combination of education and 5 years minimum of Safety and Pharmacovigilance experience. /ppPrior experience processing AE/SAE reports, generating narratives, generating and resolving safety queries, and experience with regulatory submissions to competent authorities. /ppComprehensive understanding of AEs/SAEs and ability to train others to recognize the required standards per ICH GCP guidelines; submit to client; and liaise with other cross functional groups within the agreed/ stated timelines. /ppExpert level knowledge of global regulatory requirements with experience in the pharmaceutical, biotechnology, or CRO industry, with a preference given to previous experience in a safety department within a CRO. /ph3TECHNICAL COMPETENCES SOFT SKILLS /h3pProven ability to be careful, thorough, and detail-oriented. /ppStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. /ppStrong analytical, negotiation, meeting management, cross-functional team, and leadership skills. /ppSelf-starter who thrives in a collaborative, yet less structured team environment. /ppA bility to problem-solve unstructured or ambiguous challenges. /ppStrong command of English, both written and verbal. /ppExcellent communication and interpersonal skills with customer service orientation. /ppProficient with MS Office Suite, particularly Word and Excel. /ppPermanent a uthorization to work in the U.S. /ppAbility to work remotely. /ppAbility to travel occasionally /ppbLanguages /b /pEnglishpbEducation /b /pBachelor of Science (BS): Nursing, Bachelor of Science (BS): PharmacologyppbAre you being referred to one of our roles by a connection in Alira Health? /bIf so, please apply using the referral link emailed to you. /ppJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. /ppbJob Description Summary /b /ppbJob Description /b /ph3ROLE /h3pThe Sr. Safety Scientist is an important member of the Alira Health Clinical team. This person provides technical and process-related support to safety management (clinical trial and post-market) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). The Sr. Safety Scientist is responsible for case receipt, processing, data entry, and query resolution, as well as development of project-specific safety procedures, workflows, and templates. The Sr. Safety Scientist has client-facing responsibilities and provides mentoring to team members. The Sr. Safety Scientist should have experience in multiple therapeutic areas and extensive hands-on safety database experience. /ph3KEY RESPONSABILITIES /h3ullipManages the receipt and processing of all serious adverse event (SAE) and unanticipated adverse device effect (UADE) reports from a clinical trial. /p /lilipPerforms accurate data entry of SAE/UADE information in the safety database and tracking systems (Oracle Argus or ArisGlobal LifeSphere Multivigilance preferred). /p /lilipReviews SAEs/UADEs for completeness, accuracy, and appropriateness for expedited reporting. /p /lilipDrafts safety narratives and Individual Case Summary Reports (ICSRs). /p /lilipCodes adverse events and medical history accurately using MedDRA and codes medications with WHODRUG. /p /lilipDetermines expectedness/ listedness against appropriate label. /p /lilipIdentifies clinically significant information missing from initial reports and ensures its collection. /p /lilipInitiates, tracks, and resolves requests for follow-up information from clinical sites. /p /lilipEnsures all cases receive appropriate medical review. /p /lilipPrepares follow-up correspondence and consults with the medical staff accordingly. /p /lilipEnsures all cases that require expedited reporting are processed swiftly and appropriately within required timelines. /p /lilipProvides QC of adverse event reports for other members of the safety team. /p /lilipAssists in the development of project-specific safety procedures, workflows, and templates. /p /lilipAssists in project-specific safety database set-up, development of data entry guidelines, and user acceptance testing. /p /lilipCreates and maintains project-specific working files. /p /lilipMaintains a strong understanding of safety database conventions. /p /lilipWorks with data management teams on reconciliation of safety data. /p /lilipMonitors workflow for assigned studies and programs to ensure all deadlines are met. /p /lilipAlong with senior pharmacovigilance team members, prepares Medical Monitoring Plans, Safety Plans, Data Migration Plans, and Pharmacovigilance Plans. /p /lilipParticipates in internal, client/sponsor, and other meetings as required. /p /lilipComplies with ICH GCP guidelines, FDA regulations, and company SOPs. /p /lilipManages and resolve conflicting priorities to deliver on commitments. /p /lilipPerforms additional duties as assigned. /p /li /ulh3DESIRED QUALIFICATION EXPERIENCE /h3ullipBS/BA from an undergraduate program, registered nurse, or an equivalent combination of education and 5 years minimum of Safety and Pharmacovigilance experience. /p /lilipPrior experience processing AE/SAE reports, generating narratives, generating and resolving safety queries, and experience with regulatory submissions to competent authorities. /p /lilipComprehensive understanding of AEs/SAEs and ability to train others to recognize the required standards per ICH GCP guidelines; submit to client; and liaise with other cross functional groups within the agreed/ stated timelines. /p /lilipExpert level knowledge of global regulatory requirements with experience in the pharmaceutical, biotechnology, or CRO industry, with a preference given to previous experience in a safety department within a CRO. /p /li /ulh3TECHNICAL COMPETENCES SOFT SKILLS /h3ullipProven ability to be careful, thorough, and detail-oriented. /p /lilipStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. /p /lilipStrong analytical, negotiation, meeting management, cross-functional team, and leadership skills. /p /lilipSelf-starter who thrives in a collaborative, yet less structured team environment. /p /lilipA bility to problem-solve unstructured or ambiguous challenges. /p /lilipStrong command of English, both written and verbal. /p /lilipExcellent communication and interpersonal skills with customer service orientation. /p /lilipProficient with MS Office Suite, particularly Word and Excel. /p /lilipPermanent a uthorization to work in the U.S. /p /lilipAbility to work remotely. /p /lilipAbility to travel occasionally /p /li /ulpbLanguages /b /pEnglishpbEducation /b /pBachelor of Science (BS): Nursing, Bachelor of Science (BS): PharmacologypbContract Type /b /pRegular /ph3About Us /h3pAlira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. /ph3Why Work at Alira Health? /h3pWith offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. /ph3Join Our Team /h3pWe are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience. /ppIntroduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application. /p #J-18808-Ljbffr