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Inspection Readiness and Preparation, CAPA management – work within the Pfizer QMS framework, and in collaboration with PRD Quality to ensure inspection readiness and management of CAPAs∯*∯ Other Responsibilities:Provide single point of accountability to clinical teams in their tumor type(s) for GCP advice and guidance.
$248,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support study team With supervision of medical monitor (director/Sr director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
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Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
$342,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
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Inspection Readiness and Preparation, CAPA management - work within the Pfizer QMS framework, and in collaboration with PRD Quality to ensure inspection readiness and management of CAPAs.
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This involves contributing to and participating in various quality oversight activities/committees established to drive discussion and action related to mitigating risks to the pharmacovigilance system from the use of artificial intelligence.
$223,800 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Establish guidelines, policies, and procedures for quality assurance in AI, including data validation, model validation, performance testing, and scalability testing. Provide a leadership role and acts as the Subject Matter Expert (SME) on quality and compliance metrics, regulations, process improvements, technology or specific work processes for the use of AI within the pharmacovigilance system.
$223,800 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Escalation, Communication, and Governance – work within the Pfizer QMS framework, and in collaboration with PRD Quality, to ensure quality issues are escalated from study-level Asset Quality Leads and addressed appropriately.
$248,600 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago
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