Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Safety & Pv Ai And Machine Learning Specialist

Syneos Health
Syneos Health
3-5 years
Not Disclosed
10 Jan. 12, 2026
Job Description
Job Type: Full Time Hybrid 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

Job Title: Safety & PV AI and Machine Learning Specialist

Company: Syneos Health
Location: Salem, India (Hybrid)
Job ID: 25103964
Updated: January 9, 2026


Company Overview:

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization committed to accelerating drug development and improving patient outcomes. With over 29,000 employees across 110 countries, we combine clinical, medical affairs, and commercial expertise to deliver innovative solutions that meet modern healthcare challenges.


Position Summary:

Syneos Health is seeking a Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist to advance AI-enabled safety operations. This role bridges pharmacovigilance domain expertise with hands-on AI/ML development to design, implement, and optimize solutions that improve efficiency, compliance, and decision-making across global PV processes.

The ideal candidate will have a strong background in PV or life sciences, coupled with practical experience in AI/ML development, prompt engineering for large language models (LLMs), and deployment of proof-of-concept AI applications in regulated environments.


Key Responsibilities:

AI Solution Design & Development

  • Develop and test AI/ML prototypes for PV workflows including case intake, triage, data extraction, signal detection, and narrative generation.

  • Design and optimize LLM prompt strategies to support PV automation and decision-making.

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

Technical Implementation & Integration

  • Integrate AI technologies and APIs (NLP, generative AI, process automation) into existing PV systems.

  • Partner with developers and data engineers to ensure compliant, scalable AI solutions.

Data & Model Governance

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

  • Contribute to AI governance, including documentation, explainability, and risk management in line with GxP, GDPR, and 21 CFR Part 11 standards.

Collaboration & Knowledge Sharing

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

  • Share subject matter expertise on AI trends, tools, and applications in drug safety.


Qualifications:

Education:

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

Experience:

  • 3–5+ years in pharmacovigilance, drug safety, or life sciences operations.

  • Experience developing AI/ML solutions in regulated industries.

  • Hands-on experience with Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, or OpenAI API.

  • Knowledge of NLP and LLM applications, including prompt design and optimization.

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

Preferred Skills:

  • Familiarity with PV safety databases and case processing systems.

  • Knowledge of automation and RPA tools.

  • Strong analytical, documentation, and communication skills, with the ability to explain technical concepts to non-technical stakeholders.

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


Why Join Syneos Health?

  • Lead AI-driven innovation in pharmacovigilance.

  • Work in a globally distributed team and shape the future of drug safety.

  • Access to advanced technology and tools in a regulated environment.

  • Thrive in a culture that values diversity, professional growth, and collaboration.