01Overview
DescriptionSafety & PV AI and Machine Learning SpecialistSyneos 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, youll 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 EVERYWHEREWhy Syneos HealthWe 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 were able to create a place where everyone feels like they belong.Job ResponsibilitiesJob Title:Safety & Pharmacovigilance (PV) AI and Machine Learning SpecialistDepartment:Safety & Pharmacovigilance (Safety Tech / PV Innovation)Reports To:Director, PharmacovigilancePosition OverviewThe Safety & PV AI and Machine Learning Specialist will serve as a key technical and strategic contributor to Syneos Healths 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 ResponsibilitiesAI Solution Design & DevelopmentDesign, 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 & IntegrationEvaluate 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 GovernanceSupport 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 SharingWork 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.QualificationsEducationBachelors or Masters degree in Life Sciences, Computer Science, Data Science, Engineering, or related field.Advanced degree preferred.Experience35 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.GPT4.0Understanding of GxP, 21 CFR Part 11, and data privacy requirements in the pharmaceutical industry.Understanding of global AI specific regulations and guidelines.Preferred SkillsExperience with safety databases, case processing systems, or pharmacovigilance workflows.Familiarity with automation and RPA tools.Strong analytical, communication, and .
