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Post : Senior Specialist, Pharmacovigilance System

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

Candidate Profile
• 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

Additional Information
Experience : 3–5 years
Qualification : Bachelor's degree in Life Sciences, Pharmacy
Location : New Delhi, Noida
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 30th October 2026