Director, Pharmacovigilance Intake and Regulatory Submissions
The role encompasses overseeing processes and systems for initial adverse event data intake (via electronic database capture, phone lines, etc.) to ensure compliance with global regulations.
* Responsibilities include reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners, and internal destinations in accordance with ICH-GCP guidelines and contractual obligations.
* Follow-up activities are conducted to guarantee receipt of complete and accurate safety information.
This position leads a global team responsible for all aspects of Intake and ICSR submissions across the company product portfolio, encompassing pre and post-marketing activities. Additionally, it involves oversight and maintenance of all reporting rules in the global safety database, Argus.