Practical experience in pharmacoepidemiology research
Experience authoring protocols and clinical study reports
Deep understanding of japanese claims data and dpc data
The Patient Safety Epidemiologist serves as a study lead for Post Authorization Regulatory Commitment Studies to accelerate the generation of valuable real-world evidence
Job Summary
The Patient Safety Epidemiologist serves as a study lead for Post Authorization Regulatory Commitment Studies to accelerate the generation of valuable real-world evidence.
This role requires leading cross-functional teams and providing coaching to ensure the successful execution of observational studies and consensus-building with regulatory authorities.
Candidates must possess practical experience in pharmacoepidemiology within a pharmaceutical company, academia, or CRO, along with a Master's or PhD in a relevant health science field.
Matching Summary
The Patient Safety Epidemiologist serves as a study lead for Post Authorization Regulatory Commitment Studies to accelerate the generation of valuable real-world evidence.
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 meetings in English with global teams
MPH or MSc degree in epidemiology or related field
Nice-to-have
Hands-on analysis experience using SAS, R, or SQL
Lead author experience in peer-reviewed international journals
Solid working knowledge of Japanese regulatory requirements
Ability to plan and manage project budgets
Broad knowledge of drug development lifecycle management
Key Requirements
2+ years experience for PhD holders or 5+ years for Master's holders
MPH or MSc with equivalent experience in pharmacoepidemiology
Native Japanese language proficiency required
Business English level for verbal discussions with global teams