Manager, DSPV 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 a Manager, Pharmacovigilance Agreements on the rug 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 be responsible for the end-to-end development, implementation, and lifecycle management of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs). You will ensure that pharmacovigilance contractual frameworks are executed consistently, maintained in compliance with global regulatory requirements, and aligned with Insmed’s internal policies and operational models. Additionally, you will serve as a subject matter expert for PV contractual obligations and work cross functionally to support early identification of DSPV involvement, effective safety data exchange, inspection readiness, and continuous process improvement. This role plays a critical part in supporting patient safety, regulatory compliance, and operational excellence across the organization. What You'll Do: In this role, you’ll have the opportunity to play a critical part in supporting patient safety, regulatory compliance, and operational excellence across the organization. You’ll also: Lead the development, negotiation, implementation, and maintenance of SDEAs, PVAs, and PVCs with external partners, including CROs, MAHs, licensors/licensees, distributors, and other third‑party vendors Ensure agreements are executed in a timely manner and aligned with applicable global pharmacovigilance requirements (e.g., ICH E2D, EU GVP Modules, FDA 21 CFR 314) and Insmed procedures Maintain centralized tracking and documentation of all PV agreements, ensuring appropriate version control, timely renewals, amendments, and periodic reviews Evaluate incoming and outgoing PV Agreement obligations to ensure alignment with contractual commitments Identify, assess, and escalate compliance risks, gaps, or deviations related to PV contractual obligations Support the monitoring of KPIs and metrics related to PV agreement performance and compliance Drive process improvement initiatives that enhance efficiency, consistency, data quality, and compliance across the PV agreement lifecycle Manage PV agreements within SharePoint or designated repositories and maintain the PV Contractual Provision Tracker Manage PSMF contractual updates on behalf of DSPV Pharmacovigilance Agreements including coordination, comment resolution, and quality control of final drafts Collaborate with cross‑functional stakeholders to resolve PV contract‑related issues, clarify roles and responsibilities, and address operational or compliance challenges throughout the agreement lifecycle Who You Are: You have a Bachelor’s Degree in one of the life sciences or clinical research and/or a licensed healthcare professional along with 5 years of relevant industry experience which includes 3 years of drug safety experience. You are or you also have: In-depth knowledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and current US and international pharmacovigilance regulations. Good interpersonal, written, and verbal communication skills and experience in managing partner ... (truncated, view full listing at source)