Job Description
As the Manager / Senior Manager, Drug Safety Operations, you will help lead and optimize operational aspects of pharmacovigilance across multiple clinical programs. You will be responsible for vendor relationships, ensuring compliance with global safety regulations, and managing critical processes that support patient safety and regulatory reporting.
Key Responsibilities include vendor oversight, operational management, safety database management, cross-functional collaboration, and compliance & documentation. Ensure vendor compliance with contractual obligations, timelines, and quality standards. Oversee case processing activities, including intake, triage, and timely reporting of adverse events. Manage pharmacovigilance-related quality events including change control, deviations, and CAPAs.
About Dianthus Therapeutics
We are developing potentially best in class therapies for patients living with severe autoimmune diseases.