Senior Director, PSPV Systems and Informatics

We are seeking an experienced and strategic leader to serve as the Senior Director, PSPV Systems and Informatics, leading the global PSPV systems function. This role will function as the System Owner of key PSPV platforms (e.g., safety database, signal detection systems), ensuring compliance, data integrity, and operational readiness.

The Senior Director will collaborate closely with the PSPV business owners and cross-functional teams including IT, Biometrics, QA, Regulatory Affairs, Clinical, and Commercial to deliver robust, scalable, and inspection-ready systems that support the PSPV organization’s expanding global responsibilities.

Responsibilities:

• System Ownership & Lifecycle Management
  • Serve as the System Owner for global PSPV systems (e.g., Argus, signal detection platforms), accountable for technical lifecycle, compliance, validation, and integrations
  • Maintain oversight of system configuration, user access management, and change control processes in alignment with GxP requirements
• Business Partnership & Cross-Functional Collaboration
  • Partner closely with the PSPV business owners to ensure systems support operational, scientific, and regulatory needs
  • Work collaboratively with IT, QA, Regulatory, Clinical, and Biometrics to align system capabilities with business goals
• Compliance, Validation & Audit Readiness
  • Lead system validation and periodic revalidation activities in compliance with global regulations (FDA, EMA, MHRA, PMDA, etc.)
  • Ensure audit readiness of all PSPV systems and serve as the PSPV Systems Subject Matter Expert (SME) during audits and inspections
• System Implementation & Innovation
  • Drive system implementations, migrations, and upgrades, including vendor selection, project planning, validation, training, and rollout
  • Evaluate and implement emerging technologies (e.g., automation, AI/ML, digital signal detection) to enhance system capability and efficiency
• Governance & Process Optimization
  • Establish and maintain governance models for PSPV systems including SOPs, working instructions, and system-level documentation
  • Define and monitor key performance indicators (KPIs) and key quality indicators (KQIs) for PSPV systems to ensure operational effectiveness
• Data Standards, Integration & Analytics Enablement
  • Develop and maintain PSPV data standards and lead efforts to integrate safety systems with other platforms (e.g., EDC, CTMS, regulatory systems)
  • Enable analytics and reporting by supporting data integrity, structure, and accessibility for downstream users
• Training & Change Management
  • Collaborate closely with the PSPV Compliance and training function responsible for developing and delivering role-based learning programs and embedding system SOPs
  • Lead change management planning for new tools, major system enhancements, or process transitions
• Regulatory Intelligence & Continuous Improvement
  • Stay abreast of evolving global regulatory requirements for safety systems and ensure timely implementation of changes
  • Conduct periodic system gap assessments and lead continuous improvement initiatives across the PSPV technology landscape

Preferred Skills, Qualifications and Technical Proficiencies:

• Deep understanding of PV regulations and data standards (ICH, MedDRA, WHO Drug, IDMP, etc.)
• Proven expertise in Argus Safety or similar case processing systems; strong familiarity with signal detection tools, EDC systems, and data visualization platforms (e.g., Spotfire, Tableau)
• Solid experience leading system implementations, integrations, and validation (CSV) under GxP
• Strong project management and cross-functional leadership skills
• Ability to translate complex system/data requirements into practical business solutions
• Exceptional communication and stakeholder management abilities

Preferred Education and Experience:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related field required; Advanced degree (e.g., PharmD, MS, MPH) preferred
• 15+ years of experience in the pharma or biotech industry, with at least 10 years in pharmacovigilance, including a minimum of 5 years in PV systems or informatics leadership roles
• Demonstrated expertise in GxP-compliant PV systems such as Argus or equivalent safety databases, including system validation and lifecycle management
• Proven experience leading or significantly contributing to PV system implementations, upgrades, or integrations, including collaboration with IT, QA, and external vendors
• Prior people leadership or matrix team management experience is required

The pay range that the Company reasonably expects to pay for this headquarters-based position is $275,000 - $323,500; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.