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.

 

Support Insmed QPPV - EMEA in various tasks and activities as defined by QPPV role: - Overseeing and ensuring compliance with all legal and regulatory requirements for Insmed EU/EEA and UK Marketing Authorizations. - Overseeing the safety profiles and any emerging safety concerns for Insmed EMEA Marketing Authorizations, - Being the point of contact with the European Medicines Agency (EMA) and all EU/EEA competent authorities in relation to drug safety and pharmacovigilance per the following roles: o QPPV at European level (

• Fulfil the legal and regulatory requirements for the QPPV role as defined in the EU and UK legislation and guidelines in the absence of the QPPV-EMEA or as delegated by the QPPV-EMEA.
• In the absence of the QPPV, function as a Pharmacovigilance contact point for the EEA/UK competent authorities and the EU Agency on a 24-hour basis and as a contact point for Pharmacovigilance inspections.
• In relation to the Pharmacovigilance system, together with the QPPV, is responsible for the establishment and maintenance of the Insmed Pharmacovigilance system in accordance with the legal framework for pharmacovigilance of medicinal products for human use in the EEA and in the UK.
• The (Deputy) QPPV has the authority in cooperation with the QPPV, to influence the performance of Insmed Pharmacovigilance system and its related quality system to promote, maintain and improve compliance with the legal requirements.
• Has access to the Insmed PSMF and is in a position of authority to ensure and verify that the information contained in the PSMF is accurate and up to date.
• Actively support the Insmed Local PV Network and oversight hereof as well take part in relevant meetings and presentations needed.
• Support the QPPV in relation to Eudravigilance and EMA Portals as required (communications, Eudralink, EV, IRIS).
• Collaborate with Insmed QPPV- EMEA and Global DSPV team to deliver region- and/or country-specific deliverables to meet business objectives of Insmed for EMEA such as; presentations, dashboard, budgets, meeting material and summaries as needed.
• Support oversight of GVP compliance in Insmed PV System and to provide the following:
  • Together with QPPV, receive outcomes on quality trends, performance and compliance of the pharmacovigilance system and support as needed to provide strategic input and direction on quality performance and improvement area as delegated.
  • Is informed of all Pharmacovigilance audit findings identified by PVQA and their associated CAPAs as well as any additional audits which impact the Insmed PV System.
  • Review/proofreading of various documents such as (but not limited to) global PV-owned and/or PV-related controlled documents (SOPs, WIs, Forms and Templates) related to Insmed PV system.
  • Review contracts & agreements with respect to PV and assess the need for Safety Data Exchange Agreements (SDEAs)/PVAs/PV clause as per DSPV SOP and support the preparation and maintain of contracts as per GVP requirements.
  • Review signaling and benefit-risk documentation, periodic aggregate reports, deviations/CAPAs, change controls, risk management plans, post authorization safety study as needed.
  • Participation in GVP audits/inspections as requested or needed.
  • Represent Insmed DSPV and/or the QPPV - EMEA in the EMEA region:
  • Staying abreast of all PV-related communication and documentation
  • Support and guide development/maintenance of DSPV or PV System SOPs where required.
  • Maintain an up-to-date awareness of local PV system & local regulation for EMEA and UK
  • Review and give input to signal detection activities for Insmed Marketed Products
  • In conjunction with the DSPV Global team, can act as DSPV Subject Matter Expert (SME) or project manager in tasks assigned by the QPPV.

Position Requirements:

<25% of international travels.

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Competitive compensation package including bonus 
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)

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.