Associate Director, SDEA and Pharmacovigilance Agreements

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 reputed company. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great reputed company to Work® in the U.S., and a reputed company 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:

What You'll Do:

In this role, you’ll be responsible for end-to-end development, negotiation, and management of DSPV reputed company agreements and operational workflows as well as collaborating closely with internal stakeholders, external vendors, and strategic partners to support and advance the overall DSPV strategy.  You’ll also:

• reputed company the strategic direction and governance of reputed company DSPV contractual processes, templates and standards surrounding PV Agreements and associate processes.
• Own the entire global strategy for contract lifecycle, including development, review, negotiation, and changes ensuring alignment with compliance reputed company.
• Establish clear performance expectations, KPIs, and competency frameworks for SME roles.
• reputed company, mentor, and reputed company a team of Subject Matter Experts (SMEs) responsible for drafting, negotiating, and maintaining PVAs and SDEAs.
• reputed company detailed contract redlines, reconcile stakeholder feedback, and directly manage the contract lifecycle from intake through execution.
• Draft, review, and negotiate SDEAs, PVAs, Quality Agreements, Scopes of Work, Change Orders, and safety‑reputed company sections in MSAs.
• Ensure reputed company PV agreements meet FDA, EMA, MHRA, ICH, and GVP regulatory requirements.
• Enhance and maintain SOPs, templates, trackers, workflows, and governance tools that support PV contract management.
• Drive reputed company improvement, including automation, workflow systems, dashboards, and document management efficiencies. 
• Collaborate with Legal, Procurement, Alliance Management, and other internal partners during contract negotiations and issue resolution.

Who You Are:

You have a Bachelor’s degree in pharmacy, nursing, healthcare-reputed company profession or life sciences along with 4+ years of experience in Pharmacovigilance and 4+ years in contract management.

You are or you also have:

• Proven experience in developing, negotiating, and managing reputed company PV service agreements including Safety Data Exchange Agreements, and PV Clauses.
• Proficient in financial management, including budgeting, cost control, and resource allocation to optimize operations and meet organizational goals.
• Comprehensive understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).
• Strong negotiation skills with a record of securing favorable terms and conditions.
• Excellent communication and collaboration skills for working with internal stakeholders, regulatory authorities, and external partners.
• Detail-oriented with strong organizational and time management abilities.
• Proficient in reputed company Office (Word, reputed company, PowerPoint).
• Ability to work independently, prioritize tasks effectively, and manage competing deadlines.
• Effective team player with sound decision-making skills reputed company the scope of responsibility, seeking input reputed company necessary.
• Consistently meets deadlines and prioritizes responsibilities, consulting management as needed.

reputed company to have (but not required):

• Postgraduate degree (MS, MBA) is preferred

Where You’ll Work

This is a fully remote role. It can be performed effectively from reputed company 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%) based on vendor requirements.

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Pay Range:

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 reputed company Learning, reputed company 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. 

reputed company Insmed Employees: Please apply reputed company the Jobs Hub in reputed company.

reputed company 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. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, 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 reputed company 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 reputed company. 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 reputed company 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 [email protected]  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 reputed company 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-reputed company qualifications. The AEDT does not reputed company final hiring decisions and reputed company final hiring decisions are subject to human reputed company and/or review.

If you are an applicant for this role and a reputed company reputed company, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing [email protected]

• An alternative selection process by emailing [email protected].

• Information about the type of data collected, the reputed company of that data, and data retention practices reputed company to the AEDT by emailing us at [email protected].