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.

 

	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.

 

This position is responsible for ensuring that pharmacovigilance activities are compliant with global pharmacovigilance regulations (i.e. GVP, Good Pharmacovigilance Practices), company policies, and industry standards by assisting with and supporting pharmacovigilance activities and deliverables related to document management, training, quality and compliance, and audit and inspection readiness within the scope of the Drug Safety and Pharmacovigilance (DSPV) Department at Insmed.

General:

• Collaborate cross-functionally with internal teams and external stakeholders to achieve business objectives.
• Proactively identify and implement opportunities for process optimization and efficiency improvements.
• Prepare reports, documentation, and presentations as needed.
• Assist in troubleshooting issues and resolving challenges within the scope of expertise.
• Effectively communicate findings, recommendations, and technical concepts clearly to various audiences.
• Provide comprehensive support to PV document management, training, quality and compliance, and audit and inspection readiness as needed.

PV Document Management:

• Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms.
• Assist with electronic archival and maintenance of DSPV controlled documents
• Support the maintenance of relevant team trackers, documents, and folders maintaining accuracy, organization and efficiency in document management processes.

PV Training:

• Assist with the scheduling, documentation, and tracking of all Adverse Event Reporting Trainings for all Insmed Representatives.
• Support the facilitation of DSPV training to ensure the DSPV team receives the role-specific curricula tailored to their responsibilities.

PV Quality and Compliance:

• Assist in initiating, tracking, monitoring, and following up on non-compliance matters for Insmed and PV-Related vendors as needed.
• Support the review and management of deviations, CAPAs, Quality Events, and other compliance-related activities (including but not limited to Note to Files, Storyboards, etc.) as required.

PV Audit and Inspection Readiness:

• Assist in maintaining Pharmacovigilance audit and inspection readiness by supporting preparation activities and ensuring continuous compliance with legislation.

Requirements:

$39 - $52 an hour

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

 

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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.

 

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.