Job Title:
Global Patient Safety Director
About the Role:
This is a high-level leadership position responsible for overseeing all aspects of global patient safety. The successful candidate will lead a team to ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs.
Key Responsibilities:
* Oversight of Intake processes and systems to enable initial adverse event data capture;
* Reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners, and internal destinations;
* Maintenance of reporting rules in the global safety database, Argus.
Skill Requirements:
To succeed in this role, you will need:
* Bachelor's Degree in life sciences or clinical research;
* Licensed healthcare professional required;
* A minimum of 12 years' experience in safety and reporting;