The PS Epidemiologist leads the generation of valuable real-world evidence through Post Authorization Regulatory Commitment Studies, ensuring methodological reliability and scientific robustness
Job Summary
The PS Epidemiologist leads the generation of valuable real-world evidence through Post Authorization Regulatory Commitment Studies, ensuring methodological reliability and scientific robustness.
This role involves contributing to local Risk Management Plans, formulating Pharmacovigilance Plan strategies, and leading discussions with internal stakeholders and regulatory authorities.
The position requires leading cross-functional study teams, coaching team members, and enhancing the real-world evidence generation capabilities within the organization.
Matching Summary
The PS Epidemiologist leads the generation of valuable real-world evidence through Post Authorization Regulatory Commitment Studies, ensuring methodological reliability and scientific robustness.
Skills & Requirements
Must-have
Post Authorization Regulatory Commitment Studies
real-world evidence generation
epidemiological research methodologies
cross-functional collaboration
Japanese claims data, DPC data, EMR data
Nice-to-have
external presentations and publication
enhancing RWE generation capabilities
continuous improvement of deliverable quality
cost-effectiveness and budgeting
Key Requirements
2+ years experience (PhD) or 5+ years experience (Masters)
Experience authoring and reviewing observational study protocols and CSRs
Experience conducting database studies
Experience in English discussions with global teams
MPH or MSc in pharmacoepidemiology, epidemiology or related health science field