Specialist, Drug Safety & Pharmacovigilance Operations & Vendor Management

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 Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

Supports the Drug Safety and Pharmacovigilance Operations and Vendor Management day-to-day activities in 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.
• Perform daily PV assessment of MDRs for US Product Quality Complaints. Attend Task Force meetings as DSPV Operations and Vendor Management representative.
• Support Insmed and external vendor access to the MHRA ICSR Submissions Portal.
• Oversee the creation and use of DSPV Distribution Lists and shared Mailboxes.
• Support the updates of DSPV Operations Controlled Documents.
• Support 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.
• Contribute to DSPV monthly meetings through OEC monthly updates and quarterly metrics.
• Contribute to Regulatory Compliance through accurate and timely recording of FDA IND submission notifications from Insmed Regulatory Operations.
• Perform E2B submission verifications for all Regulatory Authorities where ICSR submissions are performed through the safety gateway and accurately record results/observations.
• Support the Insmed DSPV newsletter overseeing updates and publication to enhance communication and awareness in the DSPV team.
• Facilitate the onboarding, training and mentorship of new hires within the DSPV Operations and Vendor Management Team ensuring they develop a strong understanding of pharmacovigilance processes, regulatory requirements, and vendor oversight best practices to drive operational excellence.

Position Requirements:

• Education: Bachelor’s degree or equivalent combination of relevant education/professional experience. 
• At least 1-2 years of relevant biotechnology/pharmaceutical industry experience (Pharmacovigilance experience preferred).  
• Excellent Computer literacy with Microsoft Office (Word, Excel, PowerPoint) is required. 
• Excellent organizational skills.
• Must be detailed-oriented and possess a desire to learn.
• Ability to manage competing deliverables while prioritizing time effectively based on project needs.  
• Problem solving and the ability to be coached and directed by other teammates and partners. 
• Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people.  
• Seeks guidance/input from others when faced with a difficult situation.   
• Attention to quality, detail, and accuracy. 

Salary Range

$39 - $52 an hour

Compensation & B