Job Title: Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist
Company: Syneos Health
Location: Hyderabad, India (Hybrid)
Job ID: 25103964
Updated On: 9 Jan 2026
Company Overview:
Syneos Health® is a global biopharmaceutical solutions organization delivering fully integrated clinical development, medical affairs, and commercialization services. With 29,000 employees across 110 countries, we combine innovation, technology, and scientific expertise to accelerate drug development and improve patient outcomes worldwide.
Position Summary:
The Safety & PV AI and Machine Learning Specialist will drive the exploration, development, and implementation of AI, ML, and automation solutions for pharmacovigilance processes. This role merges pharmacovigilance expertise with advanced AI/ML technical skills to optimize PV workflows, enhance efficiency, and ensure compliance with global regulatory standards.
Key Responsibilities:
AI Solution Design & Development
Design, build, and test AI/ML prototypes and proof-of-concept (POC) solutions for PV workflows including case intake, triage, data extraction, signal detection, and narrative generation.
Develop and optimize prompt engineering strategies for large language models (LLMs) to support PV automation and decision-making.
Collaborate with Safety Tech, IT, and PV Operations teams to translate operational challenges into AI opportunities.
Technical Implementation & Integration
Evaluate, implement, and integrate AI technologies, NLP tools, and APIs into existing PV systems.
Partner with developers and data engineers to ensure scalable, compliant AI solutions.
Data & Model Governance
Support AI model evaluation, validation, and monitoring to ensure regulatory compliance, accuracy, and reliability.
Contribute to AI governance frameworks, including explainability, documentation, and risk management in alignment with GxP, GDPR, and 21 CFR Part 11.
Collaboration & Knowledge Sharing
Work cross-functionally with Safety Operations, Data Science, IT, and Business Analysts to align AI initiatives with business needs.
Provide subject matter expertise on AI trends, tools, and best practices in drug safety and life sciences.
Qualifications and Skills:
Bachelor’s or Master’s degree in Life Sciences, Computer Science, Data Science, Engineering, or related field (advanced degree preferred).
3–5+ years of experience in pharmacovigilance, drug safety, or AI/ML development in regulated industries.
Hands-on experience with AI/ML model development and deployment (Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI API).
Expertise in Natural Language Processing (NLP), LLM applications, and prompt engineering.
Knowledge of GxP, 21 CFR Part 11, data privacy regulations, and global AI guidelines.
Strong analytical, communication, and documentation skills with the ability to explain complex concepts to non-technical stakeholders.
Preferred Skills:
Experience with safety databases, case processing systems, or PV workflows.
Familiarity with RPA, process automation, or AI-enabled workflow tools.
Passion for innovation, continuous improvement, and responsible AI implementation.
Why Join Syneos Health:
Be part of a forward-thinking PV team shaping the future of drug safety through ethical AI/ML solutions.
Collaborate with global teams on high-impact projects that improve patient safety outcomes.
Access professional development opportunities and participate in a culture that values inclusion, diversity, and innovation.
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