Specialist, Drug Safety & Pharmacovigilance Operations & Vendor Management

Location: Bridgewater
Posted on: June 23, 2025

Job Description:

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 Supports the Drug Safety and Pharmacovigilance Operations and Vendor Management day-to-day activities in compliance with ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures. Responsibilities Support the oversight of PV Vendor through management of Quality Check (QC) activities related to ICSR processing, regulatory reporting, and follow-up. Perform daily PV assessment of MDRs for US Product Quality Complaints. Attend Task Force meetings as DSPV Operations and Vendor Management representative. Support Insmed and external vendor access to the MHRA ICSR Submissions Portal. Oversee the creation and use of DSPV Distribution Lists and shared Mailboxes. Support the updates of DSPV Operations Controlled Documents. Support the ongoing review, update and alignment of DSPV operational documents: Joint Operating Guideline (JOG), Data Handling Conventions (DHC), Monthly Operational Report (MOR), and Safety Surveillance Forms (SSF). Provide operational support for cross-functional DSPV requests/investigations including those related to Patient Services, QA, PV, Legal, ensuring compliance with PV processes. Contribute to DSPV monthly meetings through OEC monthly updates and quarterly metrics. Contribute to Regulatory Compliance through accurate and timely recording of FDA IND submission notifications from Insmed Regulatory Operations. Perform E2B submission verifications for all Regulatory Authorities where ICSR submissions are performed through the safety gateway and accurately record results/observations. Support the Insmed DSPV newsletter overseeing updates and publication to enhance communication and awareness in the DSPV team. Facilitate the onboarding, training and mentorship of new hires within the DSPV Operations and Vendor Management Team ensuring they develop a strong understanding of pharmacovigilance processes, regulatory requirements, and vendor oversight best practices to drive operational excellence. Position Requirements: Education: Bachelor's degree or equivalent combination of relevant education/professional experience. At least 1-2 years of relevant biotechnology/pharmaceutical industry experience (Pharmacovigilance experience preferred). Excellent Computer literacy with Microsoft Office (Word, Excel, PowerPoint) is required. Excellent organizational skills. Must be detailed-oriented and possess a desire to learn. 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. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Seeks guidance/input from others when faced with a difficult situation. Attention to quality, detail, and accuracy. Salary Range $39 - $52 an hour Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here . Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Keywords: , Danbury , Specialist, Drug Safety & Pharmacovigilance Operations & Vendor Management, Science, Research & Development , Bridgewater, Connecticut