PrimeVigilance

The Specialist, Regulatory and PV Network provides the strategy based on regulatory requirements and completes regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. The Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.

The Senior Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.

This role involves database administration, supporting database creation and upgrades, change control, data migration, first-line user support, troubleshooting, and user training. The Safety System Administrator is responsible for the maintenance of database libraries and involvement in system validation activities.