Practical experience in pharmacoepidemiology research
Experience authoring protocols and clinical study reports
Deep understanding of japanese claims data and dpc data
The PSEPI serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database studies and use-result surveys
Job Summary
The PSEPI serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database studies and use-result surveys.
This role requires leading cross-functional teams to ensure methodological reliability and scientific robustness from study planning through publication.
Candidates must demonstrate the ability to hold verbal discussions beyond email correspondence with global teams in English.
Matching Summary
The PSEPI serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database studies and use-result surveys.
Skills & Requirements
Must-have
Practical experience in pharmacoepidemiology research
Experience authoring protocols and Clinical Study Reports
Deep understanding of Japanese claims data and DPC data
Ability to conduct verbal discussions in English with global teams
MPH or MSc in pharmacoepidemiology or related field
Nice-to-have
Hands-on analysis experience using SAS, R, or SQL
Experience publishing papers in peer-reviewed international journals
Solid working knowledge of Japanese regulatory requirements J-GPSP
Ability to plan and manage project budgets
Broad knowledge of drug development and lifecycle management
Key Requirements
Approx. 2+ years experience for PhD holders or 5+ years for Master's holders
MPH or MSc degree required
Native Japanese language proficiency required
Business English level required for global meetings