Job Overview
The Director, Pharmacovigilance Intake and Regulatory Submissions leads a global team responsible for pharmacovigilance intake and regulatory submissions. They oversee processes and systems for initial adverse event data intake, reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners, and internal destinations.
This role ensures compliance with ICH-GCP guidelines, regulatory requirements, and standard operating procedures.
A key aspect of this position is the management of vendors, database configuration, and assessment of study particulars and reporting requirements.
* Data automation expertise
* Advanced data validation skills
* Knowledge of clinical research and global pharmacovigilance regulations
The successful candidate will have strong leadership skills, previous people management experience, and the ability to mentor and develop direct reports. Excellent written and verbal communication skills, attention to detail, and organizational skills are required.