Syneos Health · 1 day ago
Safety & PV AI and Machine Learning Specialist
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Safety & PV AI and Machine Learning Specialist will focus on the exploration, development, and implementation of AI and machine learning solutions to enhance pharmacovigilance processes and maintain compliance with global regulatory standards.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Design, build, and test AI/ML-based prototypes and proof-of-concept solutions for PV workflows (e.g., case intake, triage, data extraction, signal detection, narrative generation)
Develop and optimize prompt engineering strategies for large language models (LLMs) to support PV automation and decision support use cases
Partner with Safety Tech, IT, and PV Operations to translate operational challenges into AI opportunities
Evaluate and integrate AI technologies and APIs (e.g., NLP, generative AI, computer vision, process automation) into existing PV systems or processes
Collaborate with developers and data engineers to ensure scalable, compliant implementation of AI tools
Support model evaluation, validation, and monitoring activities to ensure accuracy, reliability, and compliance with regulatory standards
Contribute to AI governance frameworks including documentation, explainability, and risk management in line with GxP, GDPR, and 21 CFR Part 11
Work cross-functionally with Safety Operations, Data Science, IT, and Business Analysts to align AI initiatives with PV business needs
Provide subject matter expertise on AI trends, tools, and best practices relevant to drug safety and life sciences
Qualification
Required
Bachelor's or Master's degree in Life Sciences, Computer Science, Data Science, Engineering, or related field
3–5+ years of experience in pharmacovigilance, drug safety, or life sciences operations and/or experience developing AI/ML solutions within a regulated industry
Demonstrated experience with AI/ML model development and deployment (e.g., Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI API)
Natural Language Processing (NLP) and Large Language Model (LLM) applications
Prompt design and optimization for LLM-based agents
Building proof-of-concept (POC) or pilot AI applications
Understanding of GxP, 21 CFR Part 11, and data privacy requirements in the pharmaceutical industry
Understanding of global AI specific regulations and guidelines
Preferred
Experience with safety databases, case processing systems, or pharmacovigilance workflows
Familiarity with automation and RPA tools
Strong analytical, communication, and documentation skills
Ability to communicate complex technical concepts to non-technical stakeholders
Passion for innovation, continuous improvement, and responsible AI
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Recent News
2026-01-09
2025-12-01
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