Senior Specialist, Pharmacovigilance System

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.

• 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

• 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

• 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

• 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

• 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

• Bachelors degree in Life Sciences Pharmacy Nursing Health Informatics or a related field; Masters degree preferred
• 35 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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)

• 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)

• 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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Bachelors 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 in pharmacovigilance drug safety preferred. Certification in regulatory affairs clinical safety preferred. Certification in quality management auditing preferred.

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: PharmaLex India Private Limited

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