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 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.
