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Safety & Pv Ai And Machine Learning Specialist

Syneos Health
Syneos Health
3-5+ years
preferred by company
10 Jan. 15, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 & Pharmacovigilance AI and Machine Learning Specialist

Job Requisition ID: 25103964
Employment Type: Full-Time
Work Model: Remote / Hybrid (Pre-approved)
Locations:

  • Remote: Serbia, Bulgaria

  • Hybrid: Hyderabad, Pune, Salem (India)
    Experience Required: 3–5+ Years
    Industry: Pharmacovigilance | Drug Safety | AI & Machine Learning | Life Sciences Technology


About the Company

Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating the success of its partners. By integrating clinical development, medical affairs, and commercial expertise, Syneos Health delivers impactful outcomes that improve patient lives across more than 110 countries.

Driven by innovation, digital transformation, and a patient-first approach, Syneos Health continuously evolves pharmacovigilance and safety operations through advanced technologies, including artificial intelligence and machine learning.


Role Overview

Syneos Health is seeking a Safety & Pharmacovigilance AI and Machine Learning Specialist to support and advance its Safety Technology and PV Innovation initiatives. This role will play a critical part in designing, developing, and implementing AI- and ML-driven solutions to enhance pharmacovigilance workflows, improve efficiency, and maintain strict compliance with global regulatory standards.

The ideal candidate combines pharmacovigilance or life sciences domain expertise with hands-on AI/ML development experience, particularly in building proof-of-concept solutions, working with large language models, and applying AI responsibly in regulated environments.


Key Responsibilities

AI Solution Design & Development

  • Design, develop, and validate AI/ML-based prototypes and proof-of-concept solutions for pharmacovigilance workflows such as case intake, triage, safety data extraction, signal detection, and narrative generation

  • Develop and optimize prompt engineering strategies for large language models (LLMs) to support PV automation and decision-support use cases

  • Translate operational pharmacovigilance challenges into scalable AI-driven solutions in collaboration with Safety Technology and PV Operations teams

Technical Implementation & Integration

  • Evaluate, implement, and integrate AI technologies including NLP, generative AI, automation, and analytics into existing pharmacovigilance systems

  • Collaborate with data engineers, IT teams, and developers to ensure scalable, validated, and compliant AI deployments

Model Governance & Compliance

  • Support AI model evaluation, validation, monitoring, and performance tracking

  • Contribute to AI governance frameworks including documentation, explainability, audit readiness, and risk mitigation

  • Ensure alignment with GxP, 21 CFR Part 11, GDPR, and global AI regulatory guidance

Cross-functional Collaboration

  • Partner with Safety Operations, Data Science, IT, and Business stakeholders to align AI initiatives with pharmacovigilance business objectives

  • Act as a subject matter expert on AI/ML trends, tools, and best practices within drug safety and life sciences


Education & Experience Requirements

Education:

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

  • Advanced degree preferred

Experience:

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

  • Demonstrated experience with:

    • AI/ML model development using Python and related frameworks (TensorFlow, PyTorch, Scikit-learn)

    • NLP and Large Language Model (LLM) applications, including GPT-4 or newer

    • Prompt engineering and optimization for AI agents

    • Building and validating proof-of-concept or pilot AI solutions

  • Strong understanding of regulatory requirements impacting AI in pharma, including GxP and data privacy standards


Preferred Skills & Competencies

  • Experience with pharmacovigilance systems, safety databases, or case processing workflows

  • Familiarity with automation and RPA tools

  • Strong analytical, documentation, and communication skills

  • Ability to explain complex AI concepts to non-technical stakeholders

  • High ethical standards and commitment to responsible AI use

  • Passion for innovation and continuous improvement in patient safety


Work Environment & Location

  • Remote-first role with collaboration across global teams and time zones

  • Hybrid options available for select India locations


Why Join Syneos Health

  • Be part of a globally recognized organization shaping the future of pharmacovigilance through AI

  • Work on innovative, compliant AI solutions impacting patient safety worldwide

  • Access continuous learning, career development, and cutting-edge technology exposure

  • Inclusive, diverse, and high-performance culture


Equal Opportunity Statement

Syneos Health is an equal opportunity employer committed to diversity, equity, and inclusion. All qualified applicants will receive consideration without regard to race, gender, age, disability, or any other protected characteristic.


Apply now on thepharmadaily.com to build a future-focused career at the intersection of Pharmacovigilance, AI, and Life Sciences Innovation.