Global Periodic Aggregate Safety Reports Scientist
Lilly
Bracknell, United Kingdom
Hybrid
Periodic safety reporting
Ich e2c(r2) compliance
Dsurs and pbrers/psurs submission
As a Global Periodic Aggregate Safety Reports Scientist, your purpose is to ensure effective and accurate interpretation of global periodic reporting requirements and partner in the development of processes that reflect global regulatory trends
Job Summary
As a Global Periodic Aggregate Safety Reports Scientist, your purpose is to ensure effective and accurate interpretation of global periodic reporting requirements and partner in the development of processes that reflect global regulatory trends.
Key responsibilities include preparing, maintaining, and communicating the Periodic Reporting Schedule, distributing PASRs, and preparing/submitting DSURs and PBRERs/PSURs to the EMA.
You will monitor deliverables, track regulatory changes, act as a subject matter expert, mentor team members, and collaborate across departments to ensure global compliance and quality.
Matching Summary
As a Global Periodic Aggregate Safety Reports Scientist, your purpose is to ensure effective and accurate interpretation of global periodic reporting requirements and partner in the development of processes that reflect global regulatory trends.
Skills & Requirements
Must-have
periodic safety reporting
ICH E2C(R2) compliance
DSURs and PBRERs/PSURs submission
pharmacovigilance regulations
cross-functional collaboration
quality control of data
Nice-to-have
proactive problem-solving
mentoring and supporting colleagues
building relationships across functions
subject matter expert on SOPs
Key Requirements
Bachelor's degree in healthcare, scientific, or business discipline
Understanding of pharmacovigilance regulations
Experience in periodic safety report preparation/submission
Competence with medical and therapeutic terminology