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 quality policies and strategies for customer outputs across sites and customer groups. 

• Ensure PVQO services are available across sites and customer groups to ensure needs and deliverables for the processes and products are met and promotes continuous improvement. 

• In conjunction with Head of PVQO promote cross-group consistency, standards and strategies across WWS and other partners. 

• In conjunction with Head of PVQO foster harmonization across sites, customers and processes for the integrated delivery of PVQO services; champion, maintain and instill a global perspective with a focus on strategy, promoting quality oversight and ‘Right First Time’ initiatives. 

• With the Head of PVQO ensure a global understanding of the PVQO vision and its connection to the RDM Quality Management System in support of Business Units and other Partner Lines; foster effective relationships with key internal/external customers and stakeholders. 

• Lead virtual teams for process and project-related activities. 

• Mentor and coach key PVQO staff as identified by succession plans. 

TECHNICAL SKILLSETS NEEDED

• Comprehensive knowledge of current regulations and guidelines for governing the use of artificial intelligence and impact to pharmacovigilance.

• Knowledge and experience in database system design, implementation, upgrade, or migration. 

• Technical Expertise – Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.  Proficient with software commonly used to present and analyze data (Word, PowerPoint, and Excel) required.  Knowledge of Python and other programming languages will be an asset.

• Project and Process Management & Meeting Established Deadlines – Demonstrated ability to manage complex projects and cross-functional processes, to prioritize accordingly and to meet established deadlines 

• Presentation/Influencing/Organizational Skills - Strong platform skills evident.  Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization  

• Multitasking – Demonstrated ability to effectively work on simultaneous complex projects/deliverables, prioritizing well, recognizes key issues and recommends course of action to management 

• Team and Matrix Structure – Demonstrated ability of effectively working in a team or leading a team in a matrix structure. Can interact at all levels of an organization. 

• Analytical and Statistical Skills – Demonstrated ability to analyze, evaluate, understand processes quickly, and identify gaps, issues and opportunities for improvement. Previous experience in KPIs dashboard and data visualization highly desirable. 

• Systems Technologies – Thorough understanding of system technologies that support the business.

QUALIFICATIONS

Education: 

• BS Degree (or equivalent) in computer science, engineering, or a related field.

• An advanced degree is desired, and in general, candidates for this job would have a degree in a science or technology related discipline and extensive experience within the pharmaceutical industry.  

Experience: 

• Minimum 7-10 years in quality assurance, with a focus on technologies and systems within the pharmaceutical industry. 

• Strong understanding of AI concepts, algorithms, and frameworks, such as deep learning, neural networks, reinforcement learning, etc.

• In-depth knowledge of quality assurance methodologies, tools, and best practices, with a track record of successfully implementing them in AI projects.

• Experience in developing quality plans and guidelines for AI initiatives, ensuring compliance with regulatory requirements.

• Familiarity with regulatory frameworks and standards related to AI, such as GDPR, HIPAA, ISO 27001, etc. and pharmacovigilance regulations.

• Excellent analytical and problem-solving skills, with the ability to identify risks, gaps, and areas for improvement in AI systems.

• Strong leadership and project management skills, with the ability to effectively manage oversight governance committees and drive quality initiatives.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: On premise

The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control