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 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:

We’re looking for an Associate Director, SDEA and PV 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 provide expert guidance to internal teams and leadership on regulatory requirements for pharmacovigilance (PV) contractual obligations, ensuring all agreement terms align with DSPV capabilities, quality expectations, and global PV regulations. In this role, you will serve as the functional lead responsible for the strategic development, implementation, and continuous oversight of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and PV Clauses (PVCs) within DSPV. You will ensure that all agreement frameworks are executed with operational excellence, maintained in a state of compliance with applicable regulations, and consistently aligned with evolving company policies and pharmacovigilance requirements.

What You'll Do:

In this role, you’ll be responsible for end-to-end development, negotiation, and management of DSPV related 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:

• Lead the strategic direction and governance of all 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 framework.
• Establish clear performance expectations, KPIs, and competency frameworks for SME roles.
• Lead, mentor, and develop a team of Subject Matter Experts (SMEs) responsible for drafting, negotiating, and maintaining PVAs and SDEAs.
• Perform 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‑related sections in MSAs.
• Ensure all 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 continuous 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-related 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 complex 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 Microsoft Office (Word, Excel, PowerPoint).
• Ability to work independently, prioritize tasks effectively, and manage competing deadlines.
• Effective team player with sound decision-making skills within the scope of responsibility, seeking input when necessary.
• Consistently meets deadlines and prioritizes responsibilities, consulting management as needed.

Nice 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 anywhere 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.

#LI-Remote

#LI-JK

Pay Range:

$164,000.00-213,000.00 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.

For New York City 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-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

 

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.