Global Periodic Aggregate Safety Reports Scientist
Lilly
Bracknell, United Kingdom
Hybrid
Periodic safety reporting
Global regulatory trends
Ich e2c(r2) compliance
Ensure effective and accurate interpretation of global periodic reporting requirements and partner in the development of processes that reflect global regulatory trends and guidelines
Job Summary
Ensure effective and accurate interpretation of global periodic reporting requirements and partner in the development of processes that reflect global regulatory trends and guidelines.
Prepare, maintain, and communicate the Periodic Reporting Schedule, distribute PASRs, and prepare and submit DSURs and PBRERs/PSURs to the EMA within required timelines.
Adhere to quality system documents, SOPs, and training requirements to ensure regulatory compliance and support safety inspections and audits.
Matching Summary
Ensure effective and accurate interpretation of global periodic reporting requirements and partner in the development of processes that reflect global regulatory trends and guidelines.
Skills & Requirements
Must-have
periodic safety reporting
global regulatory trends
ICH E2C(R2) compliance
DSURs and PBRERs/PSURs submission
pharmacovigilance regulations
Nice-to-have
proactive problem-solving
strong communication skills
collaborative team player
mentoring and training colleagues
Key Requirements
Bachelor’s degree in healthcare, scientific, or business discipline
Experience in periodic safety reports preparation/submission