Job Title: Safety & PV AI and Machine Learning Specialist
Company: Syneos Health
Location: Pune, India (Hybrid)
Job ID: 25103964
Updated: January 9, 2026
About Syneos Health:
Syneos Health® is a leading global biopharmaceutical solutions organization, delivering fully integrated clinical development, medical affairs, and commercialization services. With 29,000 employees across 110 countries, we accelerate drug development, improve patient outcomes, and drive innovation in healthcare.
Position Overview:
The Safety & PV AI/ML Specialist will lead initiatives to implement AI, machine learning, and automation solutions in pharmacovigilance (PV) workflows. This role combines PV expertise with hands-on AI/ML development to improve efficiency, accuracy, and regulatory compliance in global drug safety operations.
Key Responsibilities:
AI Solution Design & Development
Design, build, and test AI/ML prototypes for PV processes (case intake, triage, data extraction, signal detection, narrative generation).
Develop and optimize LLM prompt strategies for PV automation and decision support.
Collaborate with Safety Tech, IT, and PV Operations to translate operational challenges into AI solutions.
Technical Implementation & Integration
Integrate AI technologies, NLP, and APIs into PV systems.
Ensure scalable, compliant deployment in collaboration with developers and data engineers.
Data & Model Governance
Support model evaluation, validation, and monitoring to ensure regulatory compliance (GxP, GDPR, 21 CFR Part 11).
Contribute to AI governance frameworks: documentation, explainability, and risk management.
Collaboration & Knowledge Sharing
Partner with Safety Operations, Data Science, IT, and Business Analysts to align AI initiatives with PV business goals.
Share expertise on AI trends, tools, and best practices in drug safety and life sciences.
Qualifications:
Education:
Bachelor’s or Master’s degree in Life Sciences, Computer Science, Data Science, Engineering, or related field. Advanced degree preferred.
Experience:
3–5+ years in pharmacovigilance, drug safety, or AI/ML solution development in a regulated environment.
Hands-on experience with Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI API.
NLP and LLM applications, including prompt engineering.
Familiarity with GxP, 21 CFR Part 11, and global AI-specific regulations.
Preferred Skills:
Experience with PV safety databases, case processing systems, or workflows.
Knowledge of automation and RPA tools.
Strong analytical, communication, and documentation skills.
Ability to translate complex technical concepts for non-technical stakeholders.
Why Join Syneos Health?
Shape the future of PV through AI innovation.
Blend scientific expertise with cutting-edge technology to improve patient safety.
Thrive in a diverse, inclusive, and forward-thinking environment.
Collaborate with global teams across multiple time zones.
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