Manager, DSPV Pharmacovigilance Agreements

Compensation $133,000.00 - $133,000.00 / Yearly Hours Per Week 40 Number Of Positions 1 Job 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: We're looking for a Manager, Pharmacovigilance Agreements on the Drug Safety & Pharmacovigilance team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, DSPV Operational Excellence and Compliance, you'll be responsible for the end-to-end development, implementation, and lifecycle management of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs). You will ensure that pharmacovigilance contractual frameworks are executed consistently, maintained in compliance with global regulatory requirements, and aligned with Insmed's internal policies and operational models. Additionally, you will serve as a subject matter expert for PV contractual obligations and work cross functionally to support early identification of DSPV involvement, effective safety data exchange, inspection readiness, and continuous process improvement. This role plays a critical part in supporting patient safety, regulatory compliance, and operational excellence across the organization. What You'll Do: In this role, you'll have the opportunity to play a critical part in supporting patient safety, regulatory compliance, and operational excellence across the organization. You'll also: Lead the development, negotiation, implementation, and maintenance of SDEAs, PVAs, and PVCs with external partners, including CROs, MAHs, licensors/licensees, distributors, and other third-party vendors Ensure agreements are executed in a timely manner and aligned with applicable global pharmacovigilance requirements (e.g., ICH E2D, EU GVP Modules, FDA 21 CFR 314) and Insmed procedures Maintain centralized tracking and documentation of all PV agreements, ensuring appropriate version control, timely renewals, amendments, and periodic reviews Evaluate incoming and outgoing PV Agreement obligations to ensure alignment with contractual commitments Identify, assess, and escalate compliance risks, gaps, or deviations related to PV contractual obligations Support the monitoring of KPIs and metrics related to PV agreement performance and compliance Drive process improvement initiatives that enhance efficiency, consistency, data quality, and compliance across the PV agreement lifecycle Manage PV agreements within SharePoint or designated repositories and maintain the PV Contractual Provision Tracker Manage PSMF contractual updates on behalf of DSPV Pharmacovigilance Agreements including coordination, comment resolution, and quality control of final drafts Collaborate with cross-functional stakeholders to resolve PV contract-related issues, clarify roles and responsibilities, and address operational or compliance challenges throughout the agreement lifecycle Who You Are: You have a Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional along with 5 years of relevant industry experience which includes 3 years of drug safety experience. You are or you also have: In-depth knowledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and current US and international pharmacovigilance regulations. Good interpersonal, written, and verbal communication skills and experience in managing partner relationships. Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings Skilled in developing collaborative internal and external relationships and able to lead initiatives locally and globally Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Able to independently plans and organizes own work and effectively manages multiple priorities and responsibilities. Demonstrated personal accountability for taking actions that drive business decisions. Sound judgment in knowing when to escalate issues and able to make sound decisions in absence of Manager. Ability to build and maintain relationships with peers and superiors, recognize impact of work on other functional areas, and embrace tough challenges with confidence, enthusiasm, and optimism. High degree of professionalism, ability to work with limited direction, be self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks. Where You'll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements This role requires occasional travel (approximately 20%) #LI-Remote

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Pay Range: $133,000.00-173,000.00 Annual Life 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: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 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 Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back 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. 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 View email address on click.appcast.io 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. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing View email address on click.appcast.io ; and/or An alternative selection process by emailing View email address on click.appcast.io . Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at View email address on click.appcast.io . Apply here: Place of Work On-site Requisition ID R3382-3486 Insmed