Patient Safety & Pharmacovigilance Case Management Operations Lead

The Patient Safety & Pharmacovigilance (PSPV) Case Management Operations Lead provides strategic and operational oversight for global clinical and post-marketing safety operations across the product lifecycle. This role is responsible for the oversight, development, and continuous improvement of pharmacovigilance systems, processes, vendors, and teams to ensure compliance with global regulatory requirements and industry best practices.

Responsibilities:

Strategic Leadership & Organizational Management

• Provide strategic leadership and direction for global Patient Safety and Pharmacovigilance Operations supporting clinical development and post-marketing programs
• Define and execute the global safety operations strategy, operating model, and roadmap to support organizational growth and regulatory compliance
• Build, lead, mentor, and develop high-performing safety operations teams, fostering a culture of accountability, quality, compliance and continuous improvement
• Serve as a subject matter expert on pharmacovigilance operations, case management and regulatory reporting
• Establish departmental objectives, resource strategies, budgets, KPIs,  and operational metrics aligned with corporate priorities

Global Pharmacovigilance Operations

• Provide strategic oversight of global Individual Case Safety Report (ICSR) management and expedited reporting activities across clinical development and post-marketing programs
• Ensure timely and compliant submission of adverse event reports to global regulatory authorities, ethics committees and investigators
• Ensure consistent implementation of global safety reporting requirements, safety management plans and case processing procedures
• Direct operational support activities for aggregate safety reports, including DSURs, PADERs, PSURs, PBRERs, IND Annual Reports and other required regulatory submissions

Vendor Governance & Strategic Partnerships

• Provide oversight of pharmacovigilance vendors, CROs, and strategic service providers
• Establish governance frameworks, service level agreements (SLAs), KPIs, and quality metrics to ensure operational excellence and regulatory compliance
• Oversee vendor performance, budgets, contracts, issue resolution, and continuous improvement initiatives
• Ensure vendor compliance with Safety Management Plans, Safety Data Exchange Agreements (SDEAs), and applicable global regulations

Compliance, Inspection Readiness & Quality Oversight

• Ensure global pharmacovigilance operations remain inspection-ready and compliant with FDA, EMA, MHRA, PMDA, Health Canada, ICH, and other applicable global regulations
• Serve as the functional lead for Patient Safety Operations during regulatory inspections and audits
• Drive implementation and maintenance of functional SOPs, work instructions, policies and other quality documents
• Drive continuous improvement initiatives to strengthen compliance, quality, and operational performance

Safety Systems & Technology:

• Serve as the business process owner or backup for the global safety database, ensuring the system supports compliant end-to-end case processing and reporting
• Partner with Safety Systems and Technology teams to optimize system configurations, reporting rules, workflows, and data standards
• Collaborate with technology and business stakeholders to evaluate and implement innovative solutions that enhance scalability and operational effectiveness

Cross-Functional Leadership

• Collaborate effectively with Clinical Development, Medical Af