Job Description

Head Of Pharmacovigilance Information Management

The Head of PV IM serves as BioMarin's Safe Database Administrator, providing executive leadership for the technological infrastructure that supports PV system requirements to ensure patient safety across our global product portfolio. This role drives digital transformation in pharmacovigilance, designing and optimizing safety intelligence systems that handle case reports while maintaining regulatory compliance. You will lead innovation in safety database technologies, advanced analytics, and automated processes while partnering with the Global Head of Pharmacovigilance and cross-functional teams to integrate cutting-edge information management capabilities into overall safety strategy.

Key Responsibilities

Strategic Technology Leadership

• Establish the overarching PV information management strategy for BioMarin's global safety operations, aligning with corporate digital transformation objectives
• Drive innovation in safety database architecture, leveraging advanced analytics, AI/ML, and real-world data integration
• Lead development of automated systems that reduce manual effort while enhancing compliance and decision-making
• Represent information management interests at the executive leadership level, influencing technology investment decisions
• Foster a culture of data-driven safety excellence and technological innovation across the organization

Regulatory and Compliance Excellence

• Ensure all PV systems meet evolving global regulatory requirements including 21 CFR Part 11 and EU GVP standards
• Oversee technology strategy for regulatory submissions, electronic reporting, and authority interactions
• Lead system validation, inspection readiness, and regulatory compliance documentation
• Anticipate and prepare systems for evolving pharmacovigilance regulations and data requirements
• Develop strategic approaches to complex data integrity and cross-border compliance challenges

Organizational Development

• Build and develop a world-class team of PV information management professionals with hybrid expertise in technology and regulations
• Mentor senior technical leaders and safety database specialists
• Drive cross-functional collaboration between PV IM and IT, Clinical Development, Regulatory Affairs, and Medical Affairs
• Manage departmental resources, budget, and strategic technology planning
• Create career development pathways for PV information management professionals

Technology Innovation and Integration

• Champion innovative approaches to safety signal detection through advanced analytics and automated monitoring
• Lead integration of safety databases with clinical trial systems, electronic health records, and regulatory platforms
• Drive implementation of real-time dashboards and automated reporting systems for proactive decision-making
• Oversee vendor partnerships and technology relationships for continuous system optimization
• Advance integration of emerging technologies including AI, machine learning, and digital health data into safety operations

Qualifications

Education and Experience

• Bachelor's degree in computer science, Information Systems, Life Sciences, or related technical field required; master's degree or MBA preferred
• 12+ years of pharmaceutical industry experience with 8+ years in safety database management and PV information systems
• Extensive experience with major safety database platforms (Argus, Vault Safety) and regulatory compliance systems
• Track record of successfully leading complex system implementations and digital transformation initiatives

Technical Knowledge

• Expert understanding of safety database architecture and global pharmacovigilance regulatory requirements
• Deep knowledge of data integrity management, system validation, and computer system compliance (21 CFR Part 11, EU GVP)
• Strong grasp of integration technologies, APIs, ETL processes, and automated reporting systems
• Understanding of advanced analytics, machine learning applications, and signal detection methodologies
• Demonstrated ability to translate complex technical concepts for diverse stakeholders including senior executives

Leadership Capabilities

• Exceptional team building and technical organization development skills
• Strategic vision and ability to navigate complex technology and regulatory landscapes
• Strong business acumen and technology investment management capabilities
• Excellent communication and presentation skills at executive and board levels
• Proven ability to drive innovation while maintaining strict regulatory compliance and data integrity

Specialized Competencies

• Systems Architecture: Ability to design scalable, compliant systems handling safety records with 99.9%+ uptime
• Regulatory Integration: Experience with inspection readiness, authority interactions, and regulatory submission technologies
• Crisis Management: Proven capability to scale systems rapidly during high-volume periods and safety-critical situations
• Vendor Management: Strong contract negotiation and technology partnership management experience
• Change Leadership: Track record of leading digital transformation while maintaining business continuity

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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