Job Description

Company Overview
Global Biotech Pharma

Job Description
This role is mainly responsible for participating in the Drug Safety and PV operational activities, including the planning of PMS, EPPV, and conducting these activities by managing outside vendors.

• Planning and conducting PMS activities for Insmed 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
• Collaborate with global safety physicians, and other functional groups in identification, analysis for contributing to development & maintenance of product safety profile
• 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
• Provide oversight of designated CROs and Vendors, as assigned by the Head of Pharmacovigilance
• Responsible for oversight for PV inspection readiness activities and quality in collaboration with Insmed Quality Assurance

Additional Job Information
• Minimum five (5) years in Drug safety/Pharmacovigilance 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