As a Regulatory Review Advisor, Patient Safety, you will be the trusted guardian of our safety reporting, ensuring that every submission to health authorities is precise, timely, and audit-ready
Job Summary
As a Regulatory Review Advisor, Patient Safety, you will be the trusted guardian of our safety reporting, ensuring that every submission to health authorities is precise, timely, and audit-ready.
Your work will reduce risk, prevent delays, and strengthen trust with regulators worldwide.
Here, your expertise powers an enterprise driven by science and purpose, where every accurate report and informed decision can help bring therapies to patients faster.
Matching Summary
As a Regulatory Review Advisor, Patient Safety, you will be the trusted guardian of our safety reporting, ensuring that every submission to health authorities is precise, timely, and audit-ready.
Skills & Requirements
Must-have
timely and accurate submission
interpret global regulatory requirements
monitor guideline updates
pharmacovigilance reporting activities
assess process and submit ICSRs
prepare review and submit regulatory reports
maintain audit ready documentation
Nice-to-have
process improvement attitude
tight-knit collaboration skills
experience with safety databases
familiarity with MedDRA and WHODrug coding
Key Requirements
Minimum three days per week in office
Experience with safety databases and regulatory systems
Familiarity with MedDRA and WHODrug coding
Track record of leading or supporting regulatory audits