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 The Safety Scientist, Drug Safety and Pharmacovigilance (DSPV) is responsible for participating in the DSPV Medical Safety activities including but not limited to communicating with designated vendors/CROs, managing signal detection meetings, participating in regulatory inspections, individual or aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements and activities pertaining to our products. Responsibilities Responsibilities Representative responsibilities will include, but will not necessarily be limited to, the following: * Support the Medical Safety Lead in the safety review process and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches. * Author, review and support the preparation for high quality aggregate safety reports including DSUR, PBRER, PADER, SUSAR Line Listing Reports to meet internal deadlines and regulatory timelines. * Ensure all safety regulatory documents are processed and submitted according to regulatory requirements and timelines. * Draft and/or review critical documents produced for regulatory agency safety inquiries in terms of scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors. * Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, and signal evaluations. * Participate in ongoing safety data review and analysis for products in designated therapeutic areas. * Assist designated safety vendors with for acquiring follow-up information for individual cases and ensuring appropriate feedback from Global Clinical and Safety Leads. Participates with and provides oversight of Insmed DSPV Medical Safety and/or designated CROs and Vendors. * Participation with DSPV inspection readiness activities in collaboration with the Senior Director of Operations Standards and Training and Insmed Quality Assurance. * Collaborate with other Insmed functional groups like Regulatory Affairs, Clinical Development, Medical Affairs, Clinical Quality Assurance, and business units, as necessary. * Contribute to ongoing process enhancement for DSPV such as developing standard procedures and templates. * Preparation for Signal Detection Activities including data collection, review and analysis of data. * Participate in Clinical Study reconciliation activities for different products and collaboration with Insmed Data Management and vendor as needed * Contributes to and has oversight of documents such as the Safety Management Plan(s), Joint Operation Guidelines (JOG), Data Handling Conventions (DHC), etc. * Oversight and review of MedDRA with support of vendor Required and/or Preferred Skills, Experience and Education: * Bachelor's deTo view the full job description, click hereApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjg0MzkyLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t