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Job Details
The Senior Specialist, Pharmacovigilance System serves as the strategic and operational bridge between the Pharmacovigilance (PV) business/operations teams and the technical organization. This individual acts as the system 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 the 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 new feature rollouts in alignment with business strategy and regulatory requirements
Lead and manage system lifecycle activities — from business requirements definition, UAT, deployment, through to retirement — ensuring timely and quality delivery of all system milestones
Maintain and govern all business-owned system documentation , including Business Requirements Documents (BRDs), functional specifications, SOPs, user guides, and validation plans (in close collaboration with validation/QA teams)
Drive business sign-off and acceptance for all system changes, releases, and validation activities Business–IT Liaison and Stakeholder Management Act as the primary point of contact for all system-related matters between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and the Technical/IT organization Translate complex business 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 with external 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 the internal ambassador for PV systems — promoting best practices, driving adoption, and advocating for user-centric design Lead change management efforts for system rollouts and upgrades, including communication planning, training coordination, and stakeholder engagement Represent the PV systems landscape in cross-functional forums , steering committees, and process improvement initiatives Champion the adoption of innovative 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 applicable global regulatory frameworks , including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules
Collaborate with Quality Assurance to ensure systems are maintained in a validated state in accordance with GAMP 5, 21 CFR Part 11, and EU Annex 11
Support and participate in internal and external audits and regulatory inspections related to PV systems
Monitor the regulatory landscape and proactively identify impacts to systems from evolving guidance, communicating these to relevant stakeholders
Ensure data integrity, traceability, and audit trail standards are upheld across all system interactions
Operational Performance & Continuous Improvement
Define, track, and report on system KPIs and performance metrics , driving continuous improvement initiatives based on operational data
Identify and implement process optimizations at the intersection of business workflows and system capabilities
Support business continuity planning related to system downtime, data recovery, and disaster recovery scenarios
Contribute to strategic 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 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
Key Skills and Competencies
Business and Stakeholder Skills
Exceptional cross-functional communication — able to speak both "business" and "technology" fluently
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 — able to assess complex problems and drive solutions
Skilled in requirements gathering , business process mapping, and gap analysis
Effective vendor management and negotiation capabilities
Comfortable presenting to and engaging senior leadership
Personal Competencies
Detail-oriented with a quality-first mindset
Proactive, self-directed, and comfortable operating with ambiguity and autonomy
Collaborative and empathetic — a natural team enabler and culture carrier
Adaptable to a rapidly evolving technology and regulatory landscape
Demonstrates integrity and accountability , especially in a patient safety context
Technical Knowledge Requirements
PV Safety Databases & Case Management
Hands-on familiarity (business user level) with leading safety databases .
Understanding of E2B(R3) case data structure , ICSR processing workflows, MedDRA coding, and regulatory submission timelines (e.g., 7/15-day reporting)
Reporting & Analytics Tools
Experience with PV reporting platforms and dashboards, Power BI or equivalent BI tools for operational metrics CIOMS and PSUR/PBRER report generation workflows
Ability to define and validate KPI reporting requirements in collaboration with data teams
Signal Detection & Management Tools
Familiarity with signal management platforms .
Understanding of disproportionality analysis (PRR, ROR, EBGM) and signal workflow from detection through evaluation and escalation
Knowledge of EudraVigilance and FDA FAERS database structures and access
Literature Monitoring & Search Tools
Experience with or oversight of systematic literature search tools.
Understanding of ICSR extraction from literature , deduplication, and integration with safety databases.
Awareness of AI-powered literature monitoring solutions and automation capabilities in this space
Artificial Intelligence and Emerging Technologies
Awareness of AI/ML applications in pharmacovigilance , including: AI-assisted case narrative generation and MedDRA auto-coding NLP for literature monitoring and social media surveillance Predictive analytics for signal detection and risk assessment Large Language Models (LLMs) and their responsible 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 (data lineage, explainability, auditability)
Data and Integration Knowledge
Understanding of PV data flows and system integrations (e.g., CRO feeds, affiliate submissions, E2B gateway connections)
Familiarity with HL7, FHIR, 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 (not hands-on, but enough to direct and review)
Regulatory & Quality Frameworks
Solid knowledge of GVP Modules (especially I, V, VI, VIII, IX, XVI)
Working knowledge of GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and CSV/CSA (Computer Software Assurance) principles
Familiarity with ICH E2A, E2B, E2C, E2D, E2E guidelines
Understanding of audit trail requirements , data integrity standards (ALCOA+), and inspection readiness
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Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required.Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality management, auditing preferred. 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.
Full time Affiliated Companies
Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity
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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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