Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview This position is responsible for ensuring that pharmacovigilance activities are compliant with global pharmacovigilance regulations (i.e. GVP, Good Pharmacovigilance Practices), company policies, and industry standards by assisting with and supporting pharmacovigilance activities and deliverables related to document management, training, quality and compliance, and audit and inspection readiness within the scope of the Drug Safety and Pharmacovigilance (DSPV) Department at Insmed. Responsibilities General: * Collaborate cross-functionally with internal teams and external stakeholders to achieve business objectives. * Proactively identify and implement opportunities for process optimization and efficiency improvements. * Prepare reports, documentation, and presentations as needed. * Assist in troubleshooting issues and resolving challenges within the scope of expertise. * Effectively communicate findings, recommendations, and technical concepts clearly to various audiences. * Provide comprehensive support to PV document management, training, quality and compliance, and audit and inspection readiness as needed.PV Document Management: * Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms. * Assist with electronic archival and maintenance of DSPV controlled documents * Support the maintenance of relevant team trackers, documents, and folders maintaining accuracy, organization and efficiency in document management processes.PV Training: * Assist with the scheduling, documentation, and tracking of all Adverse Event Reporting Trainings for all Insmed Representatives. * Support the facilitation of DSPV training to ensure the DSPV team receives the role-specific curricula tailored to their responsibilities.PV Quality and Compliance: * Assist in initiating, tracking, monitoring, and following up on non-compliance matters for Insmed and PV-Related vendors as needed. * Support the review and management of deviations, CAPAs, Quality Events, and other compliance-related activities (including but not limited to Note to Files, Storyboards, etc.) as required.PV Audit and Inspection Readiness: * Assist in maintaining Pharmacovigilance audit and inspection readiness by supporting preparation activities and ensuring continuous compliance with legislation.Requirements: * Bachelor's degree or equivalent combination of relevant education / professional experience. * At least 1- 2 years of relevant biote chnology/ pharmaceutical industry experience (Pharmacovigi lance experience preferred). * Excellent Computer literacy with Microsoft Office (Word, Excel, PowerPoint) is required . * Ability to manage competing deliverables while prioritizing time effectively based on project needs. * Problem solving and the ability to be coached and directed by other teammates and partners . * Exemplifies honesty and integrity in dealing with others. Works effectively with differTo view the full job description, click here