Manager, Pharmacovigilance Business Operations and Vendor Strategy

Insmed Incorporated•NJ Corporate Headquarters, NJ

10d•$133,000 - $173,000•Remote

About The Position

The 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 in negotiations with pharmacovigilance service providers, manage a multi-million-dollar annual operating budget, and identify efficiencies in current spend that allow the department to invest in innovation, technology, 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.

Requirements

Minimum of a Bachelor's degree in Business Administration, Finance, Life Sciences, Public Health, or a related field
5+ years of experience in business operations, outsourcing or strategic sourcing, financial management, or project management within the pharmaceutical, biotechnology, or life sciences industry.
Direct experience in pharmacovigilance operations, drug 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 in contract management, including drafting, reviewing, and tracking vendor agreements, SOWs, and change orders.

Nice To Haves

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.

Responsibilities

Support 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 in negotiations with pharmacovigilance service providers, including 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 in collaboration with Procurement, including 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 in current pharmacovigilance spend in order to release funding for investment in innovation, technology, and artificial intelligence within DSPV.
Develop and defend the DSPV annual operating budget in partnership with the Senior Director, including 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, in collaboration with Legal, Procurement, 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.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back