Senior Specialist, Pharmacovigilance System

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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

Persona