The PS Epidemiologist serves as a study lead for Post Authorization Regulatory Commitment Studies, accelerating the generation of valuable real-world evidence
Job Summary
The PS Epidemiologist serves as a study lead for Post Authorization Regulatory Commitment Studies, accelerating the generation of valuable real-world evidence.
The role involves contributing to the development of local Risk Management Plans and leading discussions with internal stakeholders and regulatory authorities.
The PSEPI leads the education and utilization of real-world data within the Japan Patient Safety organization and contributes to organizational development.
Matching Summary
The PS Epidemiologist serves as a study lead for Post Authorization Regulatory Commitment Studies, accelerating the generation of valuable real-world evidence.
Skills & Requirements
Must-have
Post Authorization Regulatory Commitment Studies
Real-world evidence generation
Epidemiological research methodologies
Cross-functional leadership
Vendor management
Japanese claims data analysis
Nice-to-have
Process optimization
Integrity and high ethical standards
Cost-effectiveness and budgeting
Drug development lifecycle management
Key Requirements
2+ years of pharmacoepidemiology experience (PhD) or 5+ years (Masters)
Experience authoring/reviewing observational study protocols and CSRs
Experience conducting database studies
Experience with English discussions with global teams
MPH or MSc in epidemiology or related health science field