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Safety & Pv Ai And Machine Learning Specialist

Syneos Health
Syneos Health
3-5 years
Not Disclosed
10 Jan. 19, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety & PV AI and Machine Learning Specialist – Life Sciences (Hybrid – India)

Location: Gurugram, India (Hybrid)
Job Type: Full-Time
Job ID: 25103964

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating clinical development, medical affairs, and scientific innovation globally. With a presence in 110 countries and over 29,000 employees, we combine scientific expertise, technology, and operational excellence to advance patient safety and drive regulatory compliance.

We are committed to a collaborative, inclusive, and innovation-driven culture, providing employees the opportunity to work at the intersection of life sciences, pharmacovigilance, and emerging AI technologies.

Position Overview

The Safety & PV AI and Machine Learning Specialist will lead initiatives to integrate artificial intelligence (AI), machine learning (ML), and automation into pharmacovigilance operations. This role focuses on enhancing PV workflows, improving operational efficiency, and ensuring compliance with global regulatory standards.

The ideal candidate combines domain knowledge in pharmacovigilance or life sciences with hands-on AI/ML development experience, capable of designing proof-of-concept AI solutions, implementing prompt engineering strategies, and applying AI responsibly in a regulated environment.

Key Responsibilities

AI Solution Design & Development

  • Design, develop, 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 LLMs to support PV automation and decision-making.

  • Collaborate with Safety Tech, IT, and PV Operations to translate operational challenges into AI opportunities.

Technical Implementation & Integration

  • Evaluate and integrate AI technologies (NLP, generative AI, computer vision, process automation) into existing PV systems and workflows.

  • Work with developers and data engineers to ensure scalable, compliant deployment of AI solutions.

Data & Model Governance

  • Support model validation, monitoring, and performance evaluation to ensure regulatory compliance and reliability.

  • Contribute to AI governance frameworks, including documentation, explainability, and risk management per GxP, GDPR, and 21 CFR Part 11 guidelines.

Collaboration & Knowledge Sharing

  • Work cross-functionally with Safety Operations, Data Science, IT, and Business Analysts to align AI initiatives with PV business goals.

  • Provide thought leadership on AI/ML trends and best practices relevant to drug safety and life sciences.

Required Qualifications

  • Bachelor’s or Master’s degree in Life Sciences, Data Science, Computer Science, Engineering, or related field.

  • 3–5+ years of experience in pharmacovigilance, drug safety, life sciences operations, or AI/ML development within a regulated environment.

  • Hands-on experience with AI/ML model development and deployment (Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI API).

  • Knowledge of Natural Language Processing (NLP) and Large Language Models (LLMs).

  • Experience in prompt design, POC AI applications, and AI deployment in regulated industries.

  • Understanding of GxP, 21 CFR Part 11, data privacy, and global AI regulations.

Preferred Skills

  • Familiarity with safety databases and PV workflows.

  • Experience with automation and RPA tools.

  • Strong analytical, communication, and documentation skills.

  • Ability to translate complex technical concepts for non-technical stakeholders.

  • Passion for innovation, AI adoption, and continuous improvement.

Location & Work Environment

  • Hybrid work model in Gurugram, India.

  • Collaboration with global teams across multiple time zones.

Why Join Syneos Health?

  • Lead cutting-edge initiatives in AI-driven pharmacovigilance.

  • Influence the future of safety operations, regulatory compliance, and patient safety globally.

  • Work in a collaborative, diverse, and innovation-focused environment.

  • Contribute to ethical and compliant AI solutions in life sciences.

Apply now to join Syneos Health as a Safety & PV AI and Machine Learning Specialist and help shape the future of pharmacovigilance with AI innovation.