Marketed Product Safety Manager
IQVIA – Dublin – PURPOSE Coordinate and manage the preparation, review, negotiation and processing of pharmacovigilance agreements. Preparation of pharmacovigilance system master files. RESPONSIBILITIES Manage the day-to-day safety agreement development process for large complex projects Act as safety agreement expert and key interface for internal staff ensuring consistency in approach, metrics and format Manage project requirements, identify issues and interact with customers to resolve issues. Assist in the negotiation of safety agreement text using approved processes and templates Participate in complex negotiations of safety agreements as required. Resolve safety agreement disputes and / or escalate irreconcilable issues to management team Perform quality control edits on all documents Provide advice, support and guidance as needed and serve as a mentor to colleagues Represent safety agreements team at customer meetings and on internal task forces as req… – Permanent – Full-timeApply for this job.