AI Healthcare Risk Research Volunteer -- Pharma, Drug Safety, Regulatory & Clinical Research Systems (Remote)

Already, 1 in 10 patients are harmed during their medical care. Our 501c3 nonprofit works to ensure AI improves patient care rather than putting it at greater risk.We host a variety of remote volunteer opportunities. From researching the use of AI in diagnostics to creating patient education tools, and from liaising with industry to investigative journalism - BRITE Institute offers diverse ways to use your skills to save lives.,About The InitiativeThe BRITE Institute is expanding a structured AI Safety and Risk Framework initiative focused on identifying, analyzing, and documenting AI failure modes in healthcare, life sciences, and other high-risk environments.As artificial intelligence becomes increasingly integrated into pharmaceutical development, clinical research, regulatory operations, drug safety, quality systems, medical affairs, pharmacovigilance, and post-market monitoring, there is an urgent need for contributors who understand how regulated life sciences systems actually operate.This initiative is building a scalable AI safety research and intelligence framework designed to help identify where AI systems may fail across drug development, clinical research, safety surveillance, regulatory documentation, and healthcare product lifecycle management.This work is especially important because AI systems may affectPatient safetyDrug safety monitoringClinical trial operationsRegulatory submissionsPharmacovigilance workflowsQuality and compliance systemsMedical review and case assessmentProduct lifecycle managementInspection readinessPost-market surveillanceHealthcare decision-makingThis is a unique opportunity to contribute to meaningful work at the intersection ofPharmaceutical developmentDrug safetyPharmacovigilanceRegulatory affairsClinical researchQuality systemsPatient safetyAI/MLComplianceRisk managementEmerging technologyThe project operates through a standardized research workflow and collaborative system.Volunteer Roles AvailableWe are seeking contributors from a wide range of pharmaceutical, life sciences, regulatory, safety, and clinical research backgrounds, includingPharmaceutical professionalsDrug safety professionalsPharmacovigilance professionalsRegulatory affairs professionalsClinical research professionalsClinical trial coordinatorsClinical operations professionalsMedical affairs professionalsQuality assurance professionalsQuality control professionalsCompliance professionalsSafety case reviewersAdverse event reporting professionalsMedical writersRegulatory writersClinical data professionalsLife sciences project managersProduct quality complaint professionalsPost-market surveillance professionalsRIM / Veeva usersCMC regulatory professionalsNonclinical regulatory professionalsClinical regulatory professionalsSOP, work instruction, or controlled-documentation professionalsHealth authority submission professionalsPublic health or epidemiology professionalsResearch scientistsHealthcare professionals with life sciences experienceThis is a fully remote and unpaid volunteer opportunity.What You Will DoContributors may assist withIdentifying AI failure modes in pharmaceutical, drug safety, regulatory, and clinical research systemsEvaluating how AI failures may impact patient safety, product quality, compliance, and regulatory readinessReviewing real-world life sciences use cases and deployment scenariosAssessing operational realism within regulated pharmaceutical and clinical research workflowsIdentifying risks related to safety reporting, clinical trials, submissions, documentation, and monitoringEvaluating how AI tools may affect pharmacovigilance, adverse event review, and post-market surveillanceReviewing risks related to data quality, case narratives, regulatory records, and lifecycle updatesIdentifying unsafe deployment conditions and edge cases in regulated environmentsAnalyzing trust, adoption, human oversight, and accountability risksSupporting publication-oriented research outputsContributing to mitigation strategy developmentHelping ensure AI systems reflect real-world pharmaceutical, safety, and regulatory environmentsEntering finalized findings into standardized project systemsSpecial Focus AreasThis role is designed to attract contributors who understand regulated life sciences systems, includingDrug Safety and PharmacovigilanceAdverse event intakeICSR reviewSeriousness and expectedness assessmentsReportability determinationsCase narrativesSafety signal detectionPADERs and aggregate reportingPost-market surveillanceFollow-up workflowsSafety documentation qualityRegulatory Affairs and SubmissionsINDsAmendmentsAnnual reportsMeeting packagesHealth authority responsesRegulatory information management systemsSubmission bindersRegulatory objectivesProduct registration lifecycle activitiesControlled documentationSubmission readiness and traceabilityClinical Research and Trial OperationsProtocol reviewEligibility screeningClinical trial recruitmentSite documentationStudy monitoringPatient safety oversightClinical data qualityInvestigator materialsTrial risk managementReal-world evidence and study designQuality, Compliance and Inspection ReadinessSOPsWork instructionsQuality documentationProduct quality complaintsAudit trailsCorrective and preventive actionsVendor oversightCompliance workflowsInspection readinessDocumentation accuracy and completenessAI in Regulated Life Sciences WorkflowsAI-assisted medical reviewAI-generated regulatory contentAutomated case processingAI-supported clinical trial matchingAI-enabled safety surveillanceAI-assisted documentation workflowsAI-supported quality reviewAI risk in lifecycle management systemsIdeal Candidate ProfileWe are looking for contributors who areDetail-orientedHighly organizedReliable and responsiveComfortable with regulated environmentsAble to follow directions and guidanceComfortable following structured workflowsAble to work independentlyAdaptable to evolving research processesComfortable reviewing technical, clinical, regulatory, or safety-related scenariosAble to think critically about patient safety, compliance, documentation, and operational riskCapable of producing high-quality work within standardized systemsStrong Candidates Are Comfortable WithPharmaceutical operationsDrug safety workflowsPharmacovigilanceRegulatory affairsClinical research operationsQuality systemsCompliance documentationMedical reviewCase assessmentProduct lifecycle managementControlled documentationResearch-intensive workDocumentation accuracyCollaborative systemsIterative feedbackStructured templatesShared research systemsMaintaining consistency across standardized workflowsPrior AI Experience Is Helpful But Not Required.The strongest candidates will be able to apply their pharmaceutical, regulatory, safety, quality, clinical research, or healthcare experience to identify where AI systems may fail in real-world regulated environments.Why Pharma, Regulatory, Drug Safety & Clinical Research Experience MattersAI systems do not only create risk at the point of care. They may also create risk across the systems that develop, monitor, regulate, document, and oversee medical products.Contributors with pharmaceutical, drug safety, regulatory, and clinical research experience can help identify risks that purely technical reviewers may miss, includingHow adverse event cases are reviewed and reported?How safety narratives are assessed for accuracy and completeness?How regulatory documents must be created, linked, reviewed, and maintained?How clinical trial data quality affects patient safety and product development?How inspection readiness depends on traceability and documentation?How AI errors may affect submissions, reporting obligations, or lifecycle records?How human oversight is required in regulated workflows?How compliance expectations affect AI implementation?How AI adoption may create risk in pharmaceutical and clinical research systems?This role is especially valuable for people who understand the practical realities of regulated life sciences work.Important NotesThis initiative is fast-moving, systems-oriented, and research intensive.Contributors should be comfortable withLearning new workflows quicklyOperating within standardized systemsReceiving structured feedbackContributing consistently within collaborative research environmentsMeeting deadlinesUsing collaborative digital tools and remote workflowsMaintaining professionalism and accuracyRemote collaboration may includeSlackZoomGoogle MeetGoogle DocsShared spreadsheetsResearch templatesStructured data entry systemsBecause this work may contribute to future publications, policy frameworks, healthcare AI safety guidance, and advanced AI safety initiatives, the following are extremely importantProfessionalismReliabilityOperational awarenessConfidentialityAttention to detailClear communicationConsistent follow-throughWhat You’ll GainVolunteers may gainExposure to emerging AI safety researchInterdisciplinary pharmaceutical, regulatory, clinical research, and AI experiencePublication-oriented collaborationOperational and systems-thinking experienceExperience analyzing drug safety, regulatory, clinical research, and life sciences AI risksExperience working alongside technical AI contributors and researchersHands-on exposure to the rapidly growing AI/ML ecosystem impacting healthcare and life sciences globallyOpportunities to help shape safer and more accountable AI systems in regulated healthcare environmentsExperience contributing to a framework relevant to patient safety, drug development, regulatory oversight, and responsible AI adoptionThis is an opportunity to help bridge the gap between regulated life sciences systems and the future of AI-driven healthcare innovation.Additional InformationEstimated commitment approximately 8–15 hours per weekWork may include structured research, documentation, and standardized data entryThis is a merit-based and experience-based volunteer opportunityApplicants should be prepared to submit relevant work samples, research examples, writing samples, regulatory experience, drug safety experience, clinical research experience, quality documentation, life sciences experience, or related professional backgroundSelected candidates may also be asked to complete a short skills-based assessment aligned with the responsibilities outlined in this position descriptionRemote Volunteer Unpaid Flexible Hours