Manager, Pharmacovigilance Business Operations and Vendor Strategy

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 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.

What You'll Do:

In this role, you’ll have the opportunity to hold business and financial responsibility for a portfolio of global pharmacovigilance service providers and for a multi-million-dollar annual operating budget. You’ll also: 

• 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.

Who You Are:

You have a minimum of a Bachelor's degree in Business Administration, Finance, Life Sciences, Public Health, or a related field along with 5+ years of experience in business operations, outsourcing or strategic sourcing, financial management, or project management within the pharmaceutical, biotechnology, or life sciences industry.

You are or you have: 

• 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 have (but not required): 

• 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.

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 

Minimal travel expected 

#LI-EG1

#remote

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 TotalRewards@insmed.com  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.