Safety & PV AI and Machine Learning Specialist

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

Job Title:

Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist

Department:

Safety & Pharmacovigilance (Safety Tech / PV Innovation)

Reports To:

Director, Pharmacovigilance

Position Overview

The Safety & PV AI and Machine Learning Specialist will serve as a key technical and strategic contributor to Syneos Health's Safety & Pharmacovigilance (PV) AI enablement initiatives. This role will focus on the exploration, development, and implementation of artificial intelligence (AI), machine learning (ML), and automation solutions to enhance pharmacovigilance processes, improve efficiency, and maintain compliance with global regulatory standards.

The ideal candidate brings a blend of pharmacovigilance or life sciences domain knowledge and hands-on AI/ML development experience, with strong capabilities in building proof-of-concept (POC) AI agents, writing effective prompts, and applying AI responsibly in a regulated environment.

Key Responsibilities

• AI Solution Design & Development
  • Design, build, and test AI/ML-based prototypes and proof-of-concept solutions for PV workflows (e.g., case intake, triage, data extraction, signal detection, narrative generation).
  • Develop and optimize prompt engineering strategies for large language models (LLMs) to support PV automation and decision support use cases.
  • Partner with Safety Tech, IT, and PV Operations to translate operational challenges into AI opportunities.
• Technical Implementation & Integration
  • Evaluate and integrate AI technologies and APIs (e.g., NLP, generative AI, computer vision, process automation) into existing PV systems or processes.
  • Collaborate with developers and data engineers to ensure scalable, compliant implementation of AI tools.
• Data & Model Governance
  • Support model evaluation, validation, and monitoring activities to ensure accuracy, reliability, and compliance with regulatory standards.
  • Contribute to AI governance frameworks including documentation, explainability, and risk management in line with GxP, GDPR, and 21 CFR Part 11.
• Collaboration & Knowledge Sharing
  • Work cross-functionally with Safety Operations, Data Science, IT, and Business Analysts to align AI initiatives with PV business needs.
  • Provide subject matter expertise on AI trends, tools, and best practices relevant to 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 of experience in pharmacovigilance, drug safety, or life sciences operations and/or experience developing AI/ML solutions within a regulated industry.
• Demonstrated experience with:
  • AI/ML model development and deployment (e.g., Python, TensorFlow, PyTorch, Scikit-learn, Hugging Face, OpenAI API).
  • Natural Language Processing (NLP) and Large Language Model (LLM) applications.
  • Prompt design and optimization for LLM-based agents.
  • Building proof-of-concept (POC) or pilot AI applications.
  • GPT4.0+
• Understanding of GxP, 21 CFR Part 11, and data privacy requirements in the pharmaceutical industry.
• Understanding of global AI specific regulations and guidelines.

Preferred Skills

• Experience with safety databases, case processing systems, or pharmacovigilance workflows.
• Familiarity with automation and RPA tools.
• Strong analytical, communication, and documentation skills.
• Ability to communicate complex technical concepts to non-technical stakeholders.
• Passion for innovation, continuous improvement, and responsible AI.

Location & Work Environment

• Remote (Serbia or Bulgaria preferred)
• Collaboration across global teams in multiple time zones.

Why Join Syneos Health?

You'll be part of a forward-thinking pharmacovigilance team that's shaping the future of safety operations through ethical, compliant, and impactful use of AI. This is an opportunity to blend scientific expertise with cutting-edge technology to improve patient safety outcomes worldwide.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.