Specialist, Drug Safety & Pharmacovigilance Compliance at Insmed

Description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we’re in. Are you?About the Role:The Specialist DSPV Compliance 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.What You'll Do: In this role, you’ll have the opportunity to collaborate cross-functionally with internal teams and external stakeholders to achieve business objectives.You will also:<ul><li>Proactively identify and implement opportunities for process optimization and efficiency improvements.</li><li>Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms.</li><li>Assist with electronic archival and maintenance of DSPV controlled documents</li><li>Support the maintenance of relevant team trackers, documents, and folders maintaining accuracy, organization and efficiency in document management processes. </li><li>Assist with the scheduling, documentation, and tracking of all Adverse Event Reporting Trainings for all Insmed Representatives.</li><li>Support the facilitation of DSPV training to ensure the DSPV team receives the role-specific curricula tailored to their responsibilities.</li><li>Assist in initiating, tracking, monitoring, and following up on non-compliance matters for Insmed and PV-Related vendors as needed.</li><li>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.</li></ul>Who You Are:<div>You have a minimum of a Bachelor’s degree as well as at least 2 years of relevant Pharmacovigilance experience.You are or have: <ul><li>Excellent Microsoft Office (Word, Excel, PowerPoint) experience.</li><li> Proven ability to manage competing deliverables while prioritizing time effectively based on project needs.</li><li>Problem solving and the ability to be coached and directed by other teammates and partners.</li><li>Ability to seek guidance/input from others when faced with a difficult situation.   </li><li>Attention to quality, detail, and accuracy. </li><li>Up to 10% travel based on company requirements.</li></ul></div>Pay Range:$42.00-53.00 HourlyLife at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.Highlights of our U.S. offerings include:<ul><li>Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)</li><li>Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration</li><li>401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance</li><li>Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities</li><li>Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back</li></ul>Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday.<h3></h3>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.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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 <a target="_blank" href="mailto:TotalRewards@insmed.com">TotalRewards@insmed.com</a> 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.

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Specialist, Drug Safety & Pharmacovigilance Compliance

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