Senior Specialist, Pharmacovigilance System

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Job Details

TheSenior Specialist, Pharmacovigilance Systemserves as the strategic and operational bridge between the Pharmacovigilance (PV) business/operations teams and the technical organization. This individual acts as thesystem champion, business representative, and end-to-end accountability owner for one or more pharmacovigilance platforms and integrated solutions — ensuring these systems meet regulatory, operational, and quality standards throughout their lifecycle.

This is a highly cross-functional role that requires a unique blend of deep PV domain expertise, systems thinking, stakeholder management, and a forward-looking understanding of emerging technologies including AI. This person ensures those technical workstreams are effectively directed and aligned to business needs.

Key Responsibilities

System Ownership and Governance

• Serve as theaccountable 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 thesystem roadmap, prioritizing enhancements, upgrades, and new feature rollouts in alignment with business strategy and regulatory requirements
• Lead and managesystem lifecycle activities — from business requirements definition, UAT, deployment, through to retirement — ensuring timely and quality delivery of all system milestones
• Maintain and govern allbusiness-owned system documentation, including Business Requirements Documents (BRDs), functional specifications, SOPs, user guides, and validation plans (in close collaboration with validation/QA teams)
• Drivebusiness sign-off and acceptance for all system changes, releases, and validation activities

Business–IT Liaison and Stakeholder Management

• Act as theprimary point of contact for all system-related matters between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and the Technical/IT organization
• Translate complexbusiness and regulatory needs into clear, actionable technical requirements for IT developers and vendors
• Facilitate regular forums, governance meetings, and working groups to ensure alignment across business and technical stakeholders
• Manage relationships withexternal system vendors and platform providers, including participating in vendor performance reviews, roadmap discussions, and contract input where applicable
• Escalate risks, issues, and decisions through appropriate channels with clear business impact framing

System Champion and Change Enablement

• Serve as theinternal ambassador for PV systems — promoting best practices, driving adoption, and advocating for user-centric design
• Leadchange management efforts for system rollouts and upgrades, including communication planning, training coordination, and stakeholder engagement
• Represent the PV systems landscape incross-functional forums, steering committees, and process improvement initiatives
• Champion the adoption ofinnovative technologies — including AI/ML-assisted capabilities — within the PV ecosystem, evaluating feasibility and business value in partnership with IT

Compliance, Quality & Regulatory Alignment

• Ensure all systems under ownership comply with applicableglobal regulatory frameworks, including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules
• Collaborate with Quality Assurance to ensure systems are maintained in avalidated state in accordance with GAMP 5, 21 CFR Part 11, and EU Annex 11
• Support and participate ininternal and external audits and regulatory inspections related to PV systems
• Monitor the regulatory landscape and proactively identifyimpacts to systems from evolving guidance, communicating these to relevant stakeholders
• Ensure data integrity, traceability, andaudit trail standards are upheld across all system interactions

Operational Performance & Continuous Improvement

• Define, track, and report onsystem KPIs and performance metrics, driving continuous improvement initiatives based on operational data
• Identify and implementprocess optimizations at the intersection of business workflows and system capabilities
• Support business continuity planning related to system downtime, data recovery, anddisaster recovery scenarios
• Contribute tostrategic planning for the PV systems portfolio, including build/buy/partner evaluations and technology investment recommendations

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Informatics, or a related field;Master's degree preferred
• 3–5 years of experience in Pharmacovigilance, Drug Safety, or a closely related discipline
• Demonstrated experience owning or managingPV systems or technology platforms in a business capacity
• Strong understanding of theend-to-end life science lifecycle, from case intake through aggregate reporting and signal management
• Experience working in aregulated GxP environment and with validated systems

Key Skills and Competencies

Business and Stakeholder Skills

• Exceptionalcross-functional communication — able to speak both "business" and "technology" fluently
• Strongproject and program management skills; ability to manage multiple system workstreams simultaneously
• Proven ability toinfluence without authority across organizational levels and functions
• High-levelanalytical and critical thinking — able to assess complex problems and drive solutions
• Skilled inrequirements gathering, business process mapping, and gap analysis
• Effectivevendor management and negotiation capabilities
• Comfortable presenting to andengaging senior leadership

Personal Competencies

• Detail-oriented with aquality-first mindset
• Proactive, self-directed, and comfortable operating withambiguity and autonomy
• Collaborative and empathetic — a naturalteam enabler and culture carrier
• Adaptable to arapidly evolving technology and regulatory landscape
• Demonstratesintegrity and accountability, especially in a patient safety context

Technical Knowledge Requirements

PV Safety Databases & Case Management

• Hands-on familiarity (business user level) with leadingsafety databases.
• Understanding ofE2B(R3) case data structure, ICSR processing workflows, MedDRA coding, and regulatory submission timelines (e.g., 7/15-day reporting)

Reporting & Analytics Tools

• Experience withPV reporting platforms and dashboards,Power BI or equivalent BI tools for operational metricsCIOMS andPSUR/PBRER report generation workflows
• Ability to define and validateKPI reporting requirements in collaboration with data teams

Signal Detection & Management Tools

• Familiarity withsignal management platforms.
• Understanding ofdisproportionality analysis (PRR, ROR, EBGM) and signal workflow from detection through evaluation and escalation
• Knowledge ofEudraVigilance andFDA FAERS database structures and access

Literature Monitoring & Search Tools

• Experience with or oversight ofsystematic literature search tools.
• Understanding ofICSR extraction from literature, deduplication, and integration with safety databases.
• Awareness ofAI-powered literature monitoring solutions and automation capabilities in this space

Artificial Intelligence and Emerging Technologies

• Awareness ofAI/ML applications in pharmacovigilance, including: AI-assistedcase narrative generation and MedDRA auto-coding NLP forliterature monitoring and social media surveillance Predictive analytics forsignal detection and risk assessment Large Language Models (LLMs) and their responsible use in PV workflows
• Ability to critically evaluateAI vendor claims and assess technology fit for regulated PV environments
• Understanding ofAI governance requirements in GxP contexts (data lineage, explainability, auditability)

Data and Integration Knowledge

• Understanding ofPV data flows and system integrations (e.g., CRO feeds, affiliate submissions, E2B gateway connections)
• Familiarity withHL7, FHIR, E2B XML data standards
• Comfort withdata mapping, data quality principles, and working alongside data architects and engineers
• Basic understanding ofAPI-based integrations and middleware concepts (not hands-on, but enough to direct and review)

Regulatory & Quality Frameworks

• Solid knowledge ofGVP Modules (especially I, V, VI, VIII, IX, XVI)
• Working knowledge ofGAMP 5,21 CFR Part 11,EU Annex 11, andCSV/CSA (Computer Software Assurance) principles
• Familiarity withICH E2A, E2B, E2C, E2D, E2E guidelines
• Understanding ofaudit trail requirements, data integrity standards (ALCOA+), and inspection readiness

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What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

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The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

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