Director, Safety and PV Systems – Innovation, AI

Syneos Health

Director leading AI-enabled pharmacovigilance systems innovation for Syneos Health’s life-sciences services. Building prototypes, integrations, and scalable solutions across safety operations and analytics.

Posted 8/7/2026full-timeRemote • 🇵🇱 PolandLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance systems and technology solutions, with a strong focus on AI/ML prototype development, governance, and cross-functional team leadership. Capable of translating operational challenges into scalable solutions while ensuring compliance with industry standards.

Highest-signal resume keywords

Pharmacovigilance Systems ExpertiseAI/ML Prototype DevelopmentGovernance and Compliance KnowledgeCross-Functional Team LeadershipRFI/RFP Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case Intake ProcessingSignal ManagementAggregate ReportingQPPV OversightAI/NLP/RPAPrompt EngineeringModel ValidationData IntegrationAutomation SolutionsPerformance Monitoring

Soft Skills

LeadershipMentoringCollaborationCommunicationProblem Solving

Tools & Technologies

OpenAIAzure OpenAIMicrosoft CopilotData PlatformsCloud Solutions

Industry Keywords

CSV21 CFR Part 11EU Annex 11GAMP 5Safety Analytics

Tech Stack

Tools & technologies

AzureCloudRPA

About the role

Key responsibilities & impact

Own the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics
Lead cross-functional execution with internal teams and external vendors/SIs; establish governance, SLAs/KPIs, and validated deployments
Chair innovation councils with customers and partners; convert problem statements into pilots/PoCs and scale proven patterns into offerings
Serve as solution lead on RFIs/RFPs, including reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses
Publish points of view, present at conferences/webinars, brief executives, and lead demos, workshops, and innovation sessions
Manage a small senior team, including mentoring, portfolio planning, resourcing, budgets, and benefits realization
Embed risk-based quality, privacy, and security by design in partnership with QA/Compliance and Data Privacy
Design and build minimally viable AI/ML prototypes and proof of concepts, including LLM-based agents and automation solutions
Develop or use connectors and integrations between AI tools and PV systems
Translate PV operational challenges into working demos to validate feasibility and business value
Partner with engineering teams to transition POCs into scalable solutions
Design and optimize prompt frameworks and establish prompt and accuracy governance
Refine AI outputs through testing, feedback loops, and performance monitoring
Support AI model validation, monitoring, explainability, and risk management
Lead and mentor AI/PV specialists

Requirements

What you’ll need

Experience and deep expertise in pharmacovigilance systems and technology solutions
Knowledge of case intake/processing, signal management, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics
Experience with governance, SLAs/KPIs, validated deployments, CSV, 21 CFR Part 11, EU Annex 11, and GAMP 5
Experience leading cross-functional teams and external vendors/system integrators
Experience with RFIs/RFPs, reference architectures, delivery models, estimation, commercial constructs, and bid defenses
Knowledge of AI/NLP/RPA, data platforms, cloud, real-world data, and advanced analytics
Experience designing and building AI/ML prototypes, LLM-based agents, and automation solutions
Experience with OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms
Experience developing connectors and integrations using APIs, data pipelines, or middleware
Experience with prompt engineering, prompt governance, AI output testing, model validation, monitoring, explainability, and risk management
Leadership and mentoring experience
Equivalent experience, skills, and/or education will also be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive culture
Comprehensive resources including emerging technologies, data, science and knowledge sharing
Diverse career paths and employment opportunities