Manager, DSPV Operations & Vendor Management
Listed on 2026-02-07
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Healthcare
Healthcare Management, Healthcare Administration
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Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennia ls, and Best Medium Workplaces lists.
Overview
Supports the oversight of the Drug Safety and Pharmacovigilance Operations and Vendor Management activities as well as DSPV business partner relationships ensuring compliance with ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures.
Responsibilities
- Support the oversight of PV Vendor through management of Quality Check (QC) activities related to ICSR processing, regulatory reporting, and follow-up.
- Create, track, monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring.
- Identify and address any gaps in vendor case management processes.
- Serve as the primary liaison and point of contact with internal cross-functional stakeholders (QA, Patient Safety, Compliance, Commercial Strategy, Medical Affairs) to enhance PV Operational processes to ensure seamless cross-functional integration.
- Oversee and manage correspondence from PV Vendor and PV Related vendors to promptly resolve inquiries related to evaluation and processing of ICSRs.
- Contribute to the enhancement of Insmed's Pharmacovigilance System Master File (PSMF) improvement by collaborating on procedures to ensure comprehensive collection, management and reporting of case reports from all sources per Study Safety Management Plans (SMP) and Standard Operating Procedures (SOPs).
- Support the updates of DSPV Operations Controlled Documents.
- Manage the ongoing review, update and alignment of DSPV operational documents:
Joint Operating Guideline (JOG), Data Handling Conventions (DHC), Monthly Operational Report (MOR), and Safety Surveillance Forms (SSF). - Provide operational support for cross-functional DSPV requests/investigations including those related to Patient Services, QA, PV, Legal, ensuring compliance with PV processes.
- Manage updates and oversight for…
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