Post Doctoral Fellowship: Global Patient Safety

Role Summary

Post Doctoral Fellowship in Global Patient Safety, focusing on machine learning–based approaches to identify risk factors for safety topics, initially in neuroscience and expanding to other areas. Work aims to generate new clinical insights into drivers of adverse events and strengthen benefit–risk assessment for investigational and marketed therapies. The fellowship supports pharmacovigilance and safety science, with opportunities for collaboration and publication.

Responsibilities

• Develop and validate ML models to predict safety outcomes by identifying risk factors from patient histories, concomitant medications, imaging, and other clinical data.
• Apply advanced techniques for rare event prediction and model robustness, including ensemble methods and anomaly detection.
• Present findings at conferences and publish in peer‑reviewed journals.
• Assess and propose improvements to medical surveillance and signal management processes; integrate new methodologies into safety data analysis platforms.
• Collaborate with internal teams (Medical, Statistics, Toxicology, Advanced Intelligence) and external partners; support issue management and regulatory inquiries.
• Demonstrate knowledge of global regulatory requirements; contribute to safety quality system documents and training tools; support audit readiness.

Qualifications

• Basic Qualifications: An advanced analytical, statistical, bioinformatics, or medical‑related graduate degree (Ph.D., PharmD).
• Additional Skills:
  • Independent data analysis and interpretation of clinical study results.
  • Strong computer skills with experience in statistical modeling and ML; proficiency in Python and R with libraries such as scikit‑learn, XGBoost, TensorFlow.
  • Self‑directed, highly motivated, eager to learn new techniques and pursue research/publication goals.
  • Excellent verbal and written communication, presentation experience, and publication record.
  • Proficiency in data analysis and reporting.
  • Experience in drug safety is not required.

Education

Additional Requirements

• Location: Indianapolis, Indiana (office-based); remote work not considered.
• Contract: Fixed duration of two years with potential extension to three years; opportunity to pursue full-time roles after completion.