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About The RoleWe’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 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 ulatory compliance, and operational excellence across the organization.What You'll Do’ll have the opportunity to play a critical part ulatory 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 vendorsEnsure 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 proceduresMaintauring appropriate version control, timely renewals, amendments, and periodic reviewsEvaluate incoming and outgoing PV Agreement obligations to ensure alignment with contractual commitmentsIdentify, assess, and escalate compliance risks, gaps, or deviations related to PV contractual obligationsSupport the monitoring of KPIs and metrics related to PV agreement performance and complianceDrive process improvement initiatives that enhance efficiency, consistency, data quality, and compliance across the PV agreement lifecycleManage PV agreements within SharePoint or designated repositories and maintain the PV Contractual Provision TrackerManage PSMF contractual updates on behalf of DSPV Pharmacovigilance Agreements including coordination, comment resolution, and quality control of final draftsCollaborate with cross‑functional stakeholders to resolve PV contract‑related issues, clarify roles and responsibilities, and address operational or compliance challenges throughout the agreement lifecycleWho You AreYou 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 HaveIn-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 dealingsSkilled in developing collaborative internal and external relationships and able to lead initiatives locally and globallyStrong 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 maintaognize 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 WorkThis 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 RequirementsThis role requires occasional travel (approximately 20%)Life at InsmedAt 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 IncludeComprehensive 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 collaboration401(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 insuranceCompany Learning Institute providing access to Linkedll building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
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