Patient Safety & Pharmacovigilance Case Management Operations Lead

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 Affairs, Commercial, Biometrics, Data Management, Regulatory Affairs, Legal and Quality Assurance organizations
• Provide strategic input and operational expertise during product development planning, regulatory submissions and commercialization activities
• Lead cross-functional initiatives to improve operational efficiency, scalability, compliance and patient safety outcomes

Preferred Skills, Qualifications and Technical Proficiencies:

• In-depth knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
• Demonstrated leadership experience building and leading global pharmacovigilance operations within a biotechnology or pharmaceutical environment
• Proven ability to influence senior leadership and collaborate effectively with peer functional leaders across the organization
• Strong expertise in safety database systems (e.g., Argus) and electronic reporting requirements, including demonstrated success with drug safety case processing combined with a thorough knowledge of drug safety database utilization, systems and applications
• Experience leading regulatory inspections, audits, vendor governance, and quality management initiatives
• Strong strategic, organizational, and operational leadership skills with a demonstrated ability to drive transformational change and continuous improvement
• Excellent communication, stakeholder management, and decision-making skills in a complex global environment

Preferred Education and Experience:

• Degree in Healthcare (e.g., Pharmacy, Nursing, MD or a related field), advanced degree preferred
• Minimum of 12+ years of progressive experience in pharmacovigilance/patient safety within the biopharmaceutical industry, including at least 5 years in a leadership role
• Demonstrated success leading global pharmacovigilance operations supporting both clinical development and post-marketing programs
• Strong track record of driving operational excellence, process optimization, organizational transformation, and continuous improvement initiatives
• Demonstrated experience establishing and managing strategic partnerships with CROs, pharmacovigilance vendors, and service providers
• Experience leading regulatory inspections, audits, and inspection readiness activities with global health authorities (e.g., FDA, EMA, MHRA, PMDA)

The pay range that the Company reasonably expects to pay for this position is $209,100 - $340,000; 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.