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About The RoleThe Manager, Pharmacovigilance Business Operations and Vendor Strategy is responsible for the business operations, financial management, and outsourcing strategy of the Drug Safety & Pharmacovigilance (DSPV) department. A substantial portion of the organization's pharmacovigilance activity is delivered through outsourcing partners, and the way those partnerships are structured, priced, and governed has a direct effect on the speed, quality, and reliability of patient safety operations.You will lead the outsourcing strategy for DSPV, represent DSPV's interests age a multi-million-dollar annual operating budget, and identify efficiencies hnology, and artificial intelligence for pharmacovigilance. The role requires both a working understanding of pharmacovigilance operations and strong business and financial capability. This position reports to the Senior Director, DSPV Innovation & Business Solutions.What You'll DoSupport the outsourcing strategy for DSPV, including which activities are performed in-house and which are delivered by partners, the service model appropriate to each activity (full-service, functional service provider, or hybrid), and the supporting make-or-buy analysis.Represent DSPV's interests luding rate cards, unit pricing, volume tiers, service levels, and change orders, working in close partnership with Procurement and Legal. Serve as a liaison between DSPV and other functions, including Finance, Legal, Human Resources, Information Technology, Procurement, and Regulatory Affairs.Manage competitive sourcing activity for DSPV luding definition of requirements, evaluation criteria, bid analysis, and award recommendations to DSPV leadership. Define the performance standards and key performance indicators that govern partner agreements, ensuring that quality and compliance expectations carry contractual and financial consequence.Monitor the cost and resourcing model for each partner, including the relationship between case volume, workload forecasts, partner resourcing, and cost, and initiate renegotiation when the model no longer reflects actual demand.Own the DSPV spend model, including the unit costs of outsourced pharmacovigilance activity such as cost per case, cost per aggregate report, and cost per full-time equivalent.Benchmark rate cards, service models, and volumes against industry practice, and apply that analysis in negotiations and business reviews with partners.Identify and deliver efficiencies hnology, and artificial intelligence within DSPV.Develop and defend the DSPV annual operating budget luding scenario planning and multi-year projections aligned to corporate financial planning cycles and portfolio growth. Manage the DSPV financial cycle, including forecasting, variance analysis, accruals, and the purchase order (PO) process, in collaboration with Finance and Accounting. Prepare financial models, scenario analyses, and cost-benefit assessments to inform resource allocation and investment decisions within DSPV.Manage the end-to-end lifecycle of DSPV vendor contracts, including initiation, negotiation, execution, renewal, and close-out, curement, and Finance.Serve as the primary operational and business point of contact for pharmacovigilance vendor and service provider agreements, ensuring contract terms are adhered to and deliverables are met.Contribute the operational, financial, and performance content to Statements of Work (SOWs), Master Service Agreements (MSAs), and Change Orders, in partnership with Legal and Procurement.Lead resource and workforce planning for DSPV, including headcount tracking, contractor management, and the balance of in-house and outsourced activity, modeled against portfolio milestones.Who You AreYou have aminimumof a Bachelor's degree ance, Life Sciences, Public Health, or a related field along with 5+ years of experience sourcing or strategic sourcing, financial management, or project management withtechnology, or life sciences industry.You Are Or You HaveDirect experience g safety, or a closely related regulated function, with a working understanding of the activities that are commonly outsourced and of where operational risk arises.Demonstrated experience negotiating outsourcing or service agreements with contract research organizations, pharmacovigilance service providers, or comparable vendors, with measurable value delivered.Strong financial acumen, including budget ownership, unit cost analysis, forecasting, variance analysis, and business case development.Demonstrated experience luding drafting, reviewing, and tracking vendor agreements, SOWs, and change orders.Nice To Have (but Notrequired)Advanced degree (MBA or Master's in a relevant discipline).Working knowledge of global pharmacovigilance regulations (FDA, EMA GVP, ICH) and the drug development process.Experience managing competitive sourcing processes, developing vendor governance frameworks, or negotiating pharmacovigilance agreements and safety data exchange agreements.Familiarity with safety database systems. Experience supporting regulatory inspections or audits from a vendor oversight perspective.WhereYou’llWorkThis 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 eventswillbe expected.Travel RequirementsMinimal travel expectedLife 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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