Safety & Pharmacovigilance AI and Machine Learning Specialist
Updated: February 3, 2026
Location: Gurgaon, Haryana, India (Global/Remote Collaboration)
Job ID: 25103964-OTHLOC-5206-2DH
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a globally integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers data-driven, patient-centric solutions that address today’s evolving healthcare landscape.
With a workforce of over 29,000 professionals across 110 countries, Syneos Health is committed to innovation, operational excellence, and improving patient outcomes worldwide.
Role Overview
The Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist plays a critical role in advancing Syneos Health’s AI-driven pharmacovigilance transformation. This position focuses on designing, developing, and implementing artificial intelligence, machine learning, and automation solutions to enhance drug safety operations while ensuring regulatory compliance.
The ideal candidate combines strong pharmacovigilance or life sciences domain expertise with hands-on experience in AI/ML technologies, including large language models, natural language processing, and responsible AI deployment within regulated environments.
Key Responsibilities
AI & Machine Learning Solution Development
Design, develop, and test AI/ML-based proof-of-concept (POC) solutions for pharmacovigilance workflows such as case intake, triage, data extraction, signal detection, and narrative generation.
Build and optimize prompt engineering strategies for large language models (LLMs) to support safety automation and decision-support use cases.
Translate pharmacovigilance operational challenges into scalable AI-enabled solutions in collaboration with Safety Technology, IT, and PV Operations teams.
Technical Implementation & Integration
Evaluate and integrate AI technologies, APIs, and tools including NLP, generative AI, computer vision, and intelligent process automation into existing PV systems.
Collaborate with software engineers and data scientists to support scalable, validated, and compliant AI implementations.
Data Governance & Regulatory Compliance
Support model validation, performance monitoring, and documentation to ensure accuracy, reliability, and audit readiness.
Contribute to AI governance frameworks, including explainability, risk assessment, and lifecycle management in alignment with GxP, GDPR, and 21 CFR Part 11 requirements.
Maintain awareness of evolving global AI regulations and regulatory expectations impacting life sciences and pharmacovigilance.
Cross-Functional Collaboration
Partner with Safety Operations, Data Science, IT, and Business stakeholders to align AI initiatives with PV business objectives.
Act as a subject matter expert on AI, machine learning, and automation trends relevant to drug safety and regulatory science.
Communicate complex technical concepts clearly to both technical and non-technical stakeholders.
Required Qualifications
Education
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, Data Science, Engineering, or a related discipline
Advanced degree preferred
Experience
Minimum 3–5 years of experience in pharmacovigilance, drug safety, life sciences operations, and/or AI/ML development within a regulated industry
Demonstrated hands-on experience with:
AI/ML model development and deployment (Python, TensorFlow, PyTorch, Scikit-learn)
Large Language Models (LLMs) and NLP technologies
Prompt engineering and optimization for LLM-based agents
Building AI proof-of-concept or pilot applications
Generative AI platforms and APIs (including GPT-4.0 or higher)
Strong understanding of GxP, 21 CFR Part 11, data privacy, and regulatory compliance in the pharmaceutical industry
Preferred Skills
Experience with pharmacovigilance workflows, safety databases, and case processing systems
Familiarity with automation and robotic process automation (RPA) tools
Strong analytical, documentation, and problem-solving skills
Ability to work effectively in global, cross-functional teams
Demonstrated interest in ethical, responsible, and compliant AI adoption
Location & Work Environment
Primary Location: Gurgaon, Haryana, India
Collaboration with global teams across multiple time zones
Flexible work environment depending on project requirements
Why Join Syneos Health
Be part of a forward-looking pharmacovigilance innovation team
Work at the intersection of drug safety, AI, and regulatory science
Contribute to technology-driven improvements in patient safety
Access continuous learning, career development, and global exposure
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
More than 200 studies across 73,000 sites and over 675,000 clinical trial participants
Additional Information
This job description is not exhaustive and may evolve based on business needs. Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment, diversity, and accessibility regulations. Reasonable accommodations will be provided in accordance with applicable laws.
Apply now to join Syneos Health and help shape the future of pharmacovigilance through responsible and impactful AI innovation.
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