ROLE SUMMARY

The Pharmacovigilence AI Quality Oversight Lead is responsible to oversee the strategic development and implementation for the quality plans, establishing guidelines, and managing oversight governance to ensure the quality and reliability of AI systems that may affect pharmacovigilance.  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.

The incumbent leads PVQO efforts to implement and execute an AI quality framework across pharmacovigilance, commercial, clinical, medical and regulatory processes and deliverables, including strategies and operational plans for maintaining an AI inventory, quality data collection, quality metrics/measurements, trending and analysis/reporting of quality metrics, identification of corrective and preventative action planning, and incorporation of continuous improvement methodologies and tools in the continuous quality improvement framework.  This involves working with senior leaders, BPOs, business lines, digital, legal, compliance, quality groups and governance groups across the organization to drive the implementation of improvement initiatives in response to potential and real risks of AI to pharmacovigilance quality and compliance within the company. 

ROLE RESPONSIBILITIES

• Develop and implement a comprehensive quality oversight strategy for AI systems, ensuring alignment with organizational objectives, regulatory requirements, and industry best practices.

• Establish guidelines, policies, and procedures for quality assurance in AI, including data validation, model validation, performance testing, and scalability testing.

• Collaborate with cross-functional teams, including data scientists, software engineers, BPOs/SMEs, and legal/compliance teams, to define quality requirements, standards, and metrics for AI projects.

• Oversee the development of quality plans for AI initiatives, ensuring they are comprehensive, effective, and aligned with project goals.

• Manage oversight governance committees to ensure compliance with quality standards and regulatory requirements, and facilitate effective decision-making and risk management.

• Conduct regular assessments of AI projects to assess compliance with quality standards, identify gaps and areas for improvement, and provide recommendations for corrective actions.

• Collaborate with internal stakeholders and external partners to ensure alignment and adherence to quality guidelines and standards.

• Stay up-to-date with the latest advancements and trends in AI technologies, quality assurance methodologies, and regulatory requirements, and apply this knowledge to drive continuous improvement in quality oversight practices.

• Provide guidance and support to project teams on quality assurance best practices, tools, and methodologies, ensuring consistent and effective implementation across AI projects.

• Foster a culture of quality and compliance within the organization, promoting awareness and understanding of quality standards and requirements.

• Assuming a lead role in ensuring inspection readiness of behalf of SQ, including inspection risks whose origins are outside of Safety.

• In collaboration with Head of PVQO develop/evolve relevant processes for quality, compliance, continuous improvement and inspection readiness activities and ad hoc deliverables for products/customers globally. 

• Collaborate with Head of PVQO to influence key external regulators with respect to Pfizer’s position relative to Pfizer’s continuous quality improvement activities in the safety and risk management arena and interfaces with regulators, industry groups and other key external stakeholders, as appropriate. 

• Develop effective collaboration with other quality functions, linking with key stakeholders across Business Units or Partner Lines, as well as external industry and professional organizations. 

• 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. 

• Provide strategic leadership to the delivery of PVQO services, policies and works across stakeholder groups in collaboration with Head of PVQO. 

• Provide strategic oversight for the development of qual