Patient Safety & Pharmacovigilance Case Management Operations Lead

Responsibilities:
- 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 for regulatory compliance and growth
- Build, lead, mentor, and develop safety operations teams; foster 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
- Oversee global Individual Case Safety Report (ICSR) management and expedited reporting activities
- Ensure timely and compliant submission of adverse event reports to regulatory authorities, ethics committees, and investigators
- Ensure consistent implementation of safety reporting requirements, safety management plans, and case processing procedures
- Direct operational support for aggregate safety reports (DSURs, PADERs, PSURs, PBRERs, IND Annual Reports, and other regulatory submissions)
- Oversee pharmacovigilance vendors/CROs via governance frameworks, SLAs, KPIs, and quality metrics; manage performance, budgets, and contracts
- Ensure vendor compliance with Safety Management Plans, SDEAs, and applicable regulations
- Ensure inspection readiness and compliance with FDA, EMA, MHRA, PMDA, Health Canada, ICH, and other regulations
- Serve as functional lead during regulatory inspections/audits; drive SOP/policy/quality document maintenance
- Own/backup global safety database business process; optimize configurations, workflows, and reporting rules
- Partner with technology and business stakeholders to implement scalable operational solutions
- Collaborate cross-functionally (Clinical Development, Medical Affairs, Commercial, Biometrics, Data Management, Regulatory, Legal, QA)

Qualifications/Preferred Skills:
- In-depth knowledge of global PV regulations/guidelines (ICH, GVP, FDA, EMA)
- Leadership experience building and leading global PV operations in biotech/pharma
- Ability to influence senior leadership and collaborate across functions
- Expertise in safety database systems (e.g., Argus) and electronic reporting/case processing
- Experience leading regulatory inspections/audits, vendor governance, and quality initiatives
- Strong strategic, organizational, operational leadership; change and continuous improvement
- Excellent communication and stakeholder management

Preferred Education/Experience:
- Degree in healthcare (e.g., Pharmacy, Nursing, MD); advanced degree preferred
- 12+ years pharmacovigilance/patient safety in biopharma; 5+ years in leadership
- Experience leading global PV operations for clinical and post-marketing programs
- Experience managing CRO/vendor/service provider partnerships
- Experience with global health authority inspections/audit readiness (FDA, EMA, MHRA, PMDA)

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