The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS), accelerating the generation of valuable real-world evidence
Job Summary
The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS), accelerating the generation of valuable real-world evidence.
The PSEPI is responsible for the methodological reliability and scientific robustness at all stages of responsible research, from study planning and execution to study completion and publication.
As a skills leader, the PSEPI contributes to enhancing the real-world evidence (RWE) generation capabilities of PS Epidemiology & Evidence Generation members.
Matching Summary
The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS), accelerating the generation of valuable real-world evidence.
Skills & Requirements
Must-have
Pharmacoepidemiology research experience
Observational study protocol authoring
Japanese claims data analysis
English verbal discussion with global teams
Cross-functional leadership
Vendor management
Process optimization
Nice-to-have
SAS, R, or SQL analysis experience
Peer-reviewed journal publication
Japanese regulatory knowledge
Cost-effectiveness and budgeting
Drug development lifecycle knowledge
Key Requirements
2+ years of pharmacoepidemiology experience (PhD) or 5+ years (Masters)
Experience authoring/reviewing observational study protocols and CSRs
Experience with Japanese claims, DPC, and EMR data
MPH or MSc in epidemiology or related health science field