Director, Safety and PV Systems – Innovation, AI

Syneos Health

Director of Safety and PV Systems at Syneos Health responsible for technology solutions and cross-functional execution. Leading AI innovations and managing senior teams for patient safety analytics.

Posted 8/3/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in delivering end-to-end SPVG technology solutions, including AI/ML prototype development and integration with PV systems, while ensuring compliance with regulatory standards. Proven ability to lead cross-functional teams, manage projects, and mentor specialists in a fast-paced environment.

Highest-signal resume keywords

End-To-End SPVG Technology SolutionsAI/ML Prototype DevelopmentCross-Functional Team LeadershipRegulatory Compliance (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5)Data Privacy and Quality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

AI/ML PrototypingData Integration (APIs, Data Pipelines, Middleware)Advanced AnalyticsSignal ProcessingAggregate Reporting

Soft Skills

MentoringCross-Functional CollaborationInnovation LeadershipEffective Communication

Tools & Technologies

OpenAIAzure OpenAIMicrosoft CopilotNLPRPA

Industry Keywords

Pharmacovigilance (PV)Quality ManagementRisk ManagementGovernanceSLAs/KPIs

Tech Stack

Tools & technologies

AzureCloudRPA

About the role

Key responsibilities & impact

Owns 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—balancing speed, compliance, and value
Leads cross-functional execution with internal teams and external vendors/SIs; establishes governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5)
Chairs innovation councils with customers and partners; converts problem statements into pilots/PoCs with clear success criteria and scales proven patterns into offering
Serves as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses
Publishes points of view, presents at conferences/webinars, and briefs executives on the PV tech landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics)
Leads live demos, workshops and innovation sessions
Manages a small, senior team: mentors; drives portfolio planning, resourcing, budgets, and benefits realization
Embeds risk-based quality, privacy, and security by design; partners closely with QA/Compliance and Data Privacy to ensure all solutions meet regulatory, quality, and data privacy requirements
Design and build minimally viable AI/ML prototypes and proof of concepts (POCs) including LLM-based agents and automation solutions, using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms
Develop or utilize connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware)
Rapidly translate ideas to address 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 for PV use cases and establish prompt and accuracy governance
Continuously refine AI outputs through testing, feedback loops, and performance
Support AI model validation, monitoring, explainability, and risk management
Lead and mentor AI/PV specialists

Requirements

What you’ll need

Owns 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
Leads cross-functional execution with internal teams and external vendors/SIs; establishes governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5)
Chairs innovation councils with customers and partners; converts problem statements into pilots/PoCs with clear success criteria and scales proven patterns into offering
Serves as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses
Publishes points of view, presents at conferences/webinars, and briefs executives on the PV tech landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics)
Leads live demos, workshops and innovation sessions
Manages a small, senior team: mentors; drives portfolio planning, resourcing, budgets, and benefits realization
Embeds risk-based quality, privacy, and security by design; partners closely with QA/Compliance and Data Privacy to ensure all solutions meet regulatory, quality, and data privacy requirements
Design and build minimally viable AI/ML prototypes and proof of concepts (POCs) including LLM-based agents and automation solutions, using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms
Develop or utilize connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware)
Rapidly translate ideas to address 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 for PV use cases and establish prompt and accuracy governance
Continuously refine AI outputs through testing, feedback loops, and performance
Support AI model validation, monitoring, explainability, and risk management
Lead and mentor AI/PV specialists

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Committed to building an inclusive culture – where you can authentically be yourself