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
Regulatory reporting compliance
Adverse event reporting
Pharmacovigilance reporting
Global regulatory requirements
Audit and inspection readiness
Nice-to-have
Process improvement attitude
Tight-knit collaboration skills
Data quality controls
Ambitious thinking
Curiosity and honest feedback
Key Requirements
Timely and accurate submission of regulatory reports
Interpretation of global regulatory reporting requirements
Monitoring regulatory guideline updates
Coordination of pharmacovigilance reporting activities
Assessment, processing, and submission of ICSRs
Preparation, review, and submission of regulatory reports
Maintenance of documentation for regulatory audits
Collaboration with Quality Assurance, Medical Affairs, Client PS Teams
Training and mentorship on regulatory reporting
Support for audits and inspections
Contribution to Good Pharmacovigilance Practice
Support for external service providers
Completion of patient safety trainings
Access to relevant systems
Knowledge of country regulations and guidance documents