Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist

Why This Role Matters

The Safety & PV AI and Machine Learning Specialist plays a transformative role in modernizing pharmacovigilance operations through responsible and compliant use of Artificial Intelligence (AI) and Machine Learning (ML). This position bridges drug safety expertise with advanced technologies to enhance efficiency, data quality, and regulatory compliance across global safety systems.
By developing AI-driven prototypes, optimizing LLM-based workflows, and ensuring governance aligned with GxP and global regulations, the role directly contributes to improved patient safety outcomes worldwide.

Job Description

Syneos Health is seeking a Safety & PV AI and Machine Learning Specialist to support AI enablement initiatives within the Safety & Pharmacovigilance function. This role combines pharmacovigilance domain expertise with hands-on AI/ML development capabilities. The specialist will design and implement AI-powered proof-of-concept solutions, optimize prompt engineering strategies for large language models (LLMs), and ensure compliance within regulated pharmaceutical environments.

Key Features of the Role

• Position: Safety & PV AI and Machine Learning Specialist
• Department: Safety & Pharmacovigilance (Safety Tech / PV Innovation)
• Reporting To: Director, Pharmacovigilance
• Experience Required: 3–5+ years
• Location: Remote (Serbia or Bulgaria preferred)
• Industry: Clinical Research / Pharmacovigilance / AI Innovation
• Global collaboration across multiple time zones

Key Responsibilities

AI Solution Design & Development
• Design and develop AI/ML prototypes for PV workflows (case intake, triage, signal detection, narrative generation, etc.)
• Build proof-of-concept (POC) AI agents and pilot applications
• Develop and optimize prompt engineering strategies for LLM-based use cases
• Translate PV operational challenges into AI-enabled solutions

Technical Implementation & Integration
• Evaluate and integrate AI tools (NLP, generative AI, APIs, automation tools) into PV systems
• Collaborate with IT, developers, and data engineers for scalable implementation
• Ensure technical solutions meet compliance and regulatory standards

Data & Model Governance
• Support model validation, monitoring, and performance evaluation
• Contribute to AI governance frameworks (GxP, GDPR, 21 CFR Part 11)
• Ensure documentation, explainability, and risk mitigation practices are in place

Collaboration & Knowledge Sharing
• Work cross-functionally with Safety Operations, Data Science, IT, and Business teams
• Provide subject matter expertise on AI trends in drug safety
• Promote responsible AI adoption within regulated environments

Required Qualifications

Educational Background:
• 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, Life Sciences operations and/or AI/ML development in regulated industries
• Experience building AI/ML models and deploying solutions

Technical Expertise:
• Proficiency in Python and AI/ML frameworks (TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI APIs)
• Strong experience in NLP and LLM applications
• Prompt engineering for GPT-4.0+ or similar LLMs
• Experience building proof-of-concept AI applications
• Understanding of GxP, 21 CFR Part 11, GDPR, and global AI regulations

Preferred Skills:
• Experience with safety databases and PV workflows
• Familiarity with automation and RPA tools
• Strong analytical and documentation skills
• Ability to explain complex technical concepts to non-technical stakeholders
• Passion for ethical and responsible AI implementation

Company Overview

Syneos Health is a leading fully integrated biopharmaceutical solutions organization operating across 110 countries with over 29,000 employees. The company supports clinical development, medical affairs, and commercialization activities for global pharmaceutical clients.
Over the past five years, Syneos Health has contributed to 94% of Novel FDA-approved drugs and 95% of EMA-authorized products. The organization fosters innovation, diversity, and a “Total Self” culture that encourages employees to bring their authentic selves to work.

FAQs

Q1. Is pharmacovigilance experience mandatory?
Yes, domain knowledge in PV or drug safety is strongly preferred.

Q2. Is hands-on AI development required?
Yes, practical AI/ML development and POC building experience is essential.

Q3. Does the role require regulatory knowledge?
Yes, strong understanding of GxP, 21 CFR Part 11, GDPR, and global AI regulations is required.

Q4. Is this purely technical or strategic?
It is both—combining hands-on development with strategic AI enablement initiatives.

Q5. Is the position fully remote?
Yes, remote with preference for Serbia or Bulgaria-based candidates.

Application Tip

• Highlight AI/ML projects in regulated environments
• Showcase prompt engineering and LLM application experience
• Mention PV or safety database exposure
• Include governance, validation, and compliance experience
• Demonstrate ability to bridge technical and business stakeholders