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 f ... (truncated, view full listing at source)