Job Description

Company Overview
Pharmaceuticals Company

Job Description
• Planning and conducting PMS activities for Medical products
• Manage the relationship with Pharmacovigilance providers and internal personnel
• Contribute to the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the pharmacovigilance activities
• Support and/or draft regulatory inquiry responses related to pharmacovigilance/safety issues to regulatory agencies, EC/IRB, Investigators, and ad hoc inquiries
• Provide input and review to key regulatory or clinical documents (i.e., clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc.) related to pharmacovigilance
• Participate in internal global pharmacovigilance meetings as well as joint safety meetings with partners if needed

• Minimum five (5) years in PMS in pharmaceutical industries setting with both investigational and marketed products
• Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation) is essential
• Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
• Active participation in regulatory inspections is a plus
• At least two (2) years of experience with, aggregate safety reporting, safety surveillance, signal management and/or Risk management