Senior Specialist, Pharmacovigilance System

• Serve as accountable business system owner for PV-related platforms, including safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms
• Own and maintain the system roadmap, prioritizing enhancements, upgrades, and feature rollouts aligned with business strategy and regulatory requirements
• Lead system lifecycle activities from business requirements definition and UAT through deployment and retirement
• Maintain and govern business-owned system documentation, including BRDs, functional specifications, SOPs, user guides, and validation plans
• Drive business sign-off and acceptance for system changes, releases, and validation activities
• Act as primary liaison between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and Technical/IT teams
• Translate business and regulatory needs into actionable technical requirements for developers and vendors
• Facilitate governance meetings, forums, and working groups
• Manage external system vendor and platform-provider relationships, including performance reviews, roadmap discussions, and contract input
• Escalate risks, issues, and decisions with clear business-impact framing
• Promote best practices, system adoption, and user-centric design as the internal PV systems champion
• Lead change management for system rollouts and upgrades, including communications, training coordination, and stakeholder engagement
• Represent the PV systems landscape in cross-functional forums, steering committees, and process-improvement initiatives
• Evaluate and champion AI/ML-assisted capabilities in partnership with IT
• Ensure systems comply with global regulatory frameworks including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules
• Collaborate with Quality Assurance to maintain validated systems under GAMP 5, 21 CFR Part 11, and EU Annex 11
• Support internal and external audits and regulatory inspections
• Monitor regulatory changes and communicate system impacts to stakeholders
• Ensure data integrity, traceability, and audit-trail standards
• Define, track, and report system KPIs and performance metrics
• Identify and implement process optimizations at the intersection of workflows and system capabilities
• Support business continuity planning for downtime, data recovery, and disaster recovery
• Contribute to PV systems portfolio strategy, build/buy/partner evaluations, and technology investment recommendations

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Informatics, or a related field; Master's degree preferred
• Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required
• 3–5 years of experience in Pharmacovigilance, Drug Safety, or a closely related discipline
• 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required
• Demonstrated experience owning or managing PV systems or technology platforms in a business capacity
• Strong understanding of the end-to-end life science lifecycle, from case intake through aggregate reporting and signal management
• Experience working in a regulated GxP environment and with validated systems
• Exceptional cross-functional communication and ability to translate between business and technology
• Strong project and program management skills; ability to manage multiple system workstreams simultaneously
• Proven ability to influence without authority across organizational levels and functions
• High-level analytical and critical thinking skills
• Skilled in requirements gathering, business process mapping, and gap analysis
• Effective vendor management and negotiation capabilities
• Comfortable presenting to and engaging senior leadership
• Hands-on familiarity with leading safety databases at business-user level
• Understanding of E2B(R3) case data structure, ICSR processing workflows, MedDRA coding, and regulatory submission timelines
• Experience with PV reporting platforms and dashboards, Power BI or equivalent BI tools, and CIOMS and PSUR/PBRER report generation workflows
• Ability to define and validate KPI reporting requirements in collaboration with data teams
• Familiarity with signal management platforms and disproportionality analysis (PRR, ROR, EBGM)
• Knowledge of EudraVigilance and FDA FAERS database structures and access
• Experience with or oversight of systematic literature search tools
• Understanding of ICSR extraction from literature, deduplication, and integration with safety databases
• Awareness of AI/ML applications, AI-powered literature monitoring, automation, NLP, predictive analytics, LLMs, and responsible AI use in PV workflows
• Ability to critically evaluate AI vendor claims and assess technology fit for regulated PV environments
• Understanding of AI governance requirements in GxP contexts, including data lineage, explainability, and auditability
• Understanding of PV data flows and system integrations, including CRO feeds, affiliate submissions, and E2B gateway connections
• Familiarity with HL7, FHIR, and E2B XML data standards
• Comfort with data mapping, data quality principles, and working alongside data architects and engineers
• Basic understanding of API-based integrations and middleware concepts
• Solid knowledge of GVP Modules I, V, VI, VIII, IX, and XVI
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and CSV/CSA principles
• Familiarity with ICH E2A, E2B, E2C, E2D, and E2E guidelines
• Understanding of audit trail requirements, ALCOA+ data integrity standards, and inspection readiness
• Certification in pharmacovigilance, drug safety, regulatory affairs, clinical safety, quality management, or auditing preferred

• Benefit offerings outside the US may vary by country and will be aligned to local market practice
• Equal employment opportunity and non-discriminatory recruiting, training, compensation, benefits, promotions, and transfers
• Reasonable accommodations during the employment process for individuals with disabilities