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Syneos Health®, a global leader in biopharmaceutical solutions, is hiring a Safety & Pharmacovigilance (PV) AI and Machine Learning Specialist to support its next-generation PV innovation and safety technology initiatives.
This opportunity is ideal for professionals with a strong background in pharmacovigilance, drug safety, and artificial intelligence (AI/ML) who want to work at the intersection of regulatory-compliant AI, patient safety, and advanced analytics.
With remote and hybrid work options across India and Europe, this role offers exposure to global safety operations, cutting-edge AI tools (LLMs, NLP, automation), and real-world regulated environments.
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Job Overview
- Job Title: Safety & PV AI and Machine Learning Specialist
- Department: Safety & Pharmacovigilance – Safety Tech / PV Innovation
- Employment Type: Full-time
- Work Mode: Remote / Hybrid
- Locations:
- India – Pune, Hyderabad, Salem (Hybrid)
- Serbia (Remote)
- Bulgaria (Remote)
Key Responsibilities
AI & Machine Learning for Pharmacovigilance
- Design and develop AI/ML proof-of-concept (POC) solutions for pharmacovigilance workflows.
- Apply Large Language Models (LLMs) for:
- Case intake and triage
- Narrative generation
- Data extraction and signal detection
- Perform prompt engineering and optimization for PV automation use cases.
Technical Integration & Innovation
- Integrate AI technologies such as NLP, Generative AI, computer vision, and APIs into existing PV systems.
- Collaborate with Safety Tech, IT, Data Science, and PV Operations teams.
- Translate PV operational challenges into scalable AI solutions.
Governance & Compliance
- Support model validation, monitoring, and documentation.
- Ensure AI solutions comply with GxP, GDPR, and 21 CFR Part 11.
- Contribute to AI governance, explainability, and risk management frameworks.
Cross-Functional Collaboration
- Act as a subject matter expert on AI trends in drug safety.
- Communicate complex technical concepts to non-technical stakeholders.
Qualifications & Experience
Education
- Bachelor’s or Master’s degree in:
- Life Sciences
- Pharmacy
- Computer Science
- Data Science
- Engineering or related discipline
- Advanced degree preferred.
Experience
- 3–5+ years experience in:
- Pharmacovigilance / Drug Safety / Life Sciences operations OR
- AI/ML development in a regulated industry
- Hands-on experience with:
- Python, TensorFlow, PyTorch, Scikit-learn
- NLP and LLM applications (GPT-4 or above)
- Hugging Face, OpenAI APIs
- AI POC or pilot implementations
Regulatory Knowledge
- Strong understanding of:
- Pharmacovigilance workflows
- Global PV regulations
- AI-specific regulatory expectations
Preferred Skills
- Experience with safety databases and case processing systems
- Familiarity with RPA and automation tools
- Strong documentation and stakeholder communication skills
- Passion for responsible AI and patient safety innovation
Why Join Syneos Health?
- Work with 94% of FDA-approved novel drugs
- Exposure to global PV innovation programs
- Career growth through training, mentorship, and leadership support
- Inclusive Total Self culture
- Opportunity to shape the future of AI-enabled pharmacovigilance
Estimated Salary (India)
- ₹18,00,000 – ₹30,00,000 per annum
(Salary may vary based on experience, location, and skill set)
How to Apply
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