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.

 

Reporting to the Sr Director, Quality Assurance - Pharmacovigilance, the Manager of Pharmacovigilance Quality Assurance serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance (DSPV), Medical Information (MI), and Clinical Departments. The incumbent will provide support and promote collaboration with cross functional internal and external teams to ensure all systems, processes and outcomes comply with applicable global standards, regulations and guidelines.

Responsibilities:

• Support the evaluation and acceptability of vendors, partners and other external organizations related to Pharmacovigilance (PV) activities such as Patient Support Programs, Specialty Pharmacies, and Market Research, for qualification.
• Conduct and/or assist with the completion and evaluation of supplier pre-qualification surveys
• Creation and maintenance of vendor organization records related to PV activities in the QMS system
• Conduct internal and external risk assessments of PV process systems, vendors, partners, and other external organizations related to PV activities.
• Provide input into the annual audit schedule for internal and external audits related to PV activities based on the output of the risk assessments.
• Lead or co-lead internal and external pharmacovigilance audits (such as PV process systems, Patient Support Programs, Market Research, Specialty Pharmacies) including planning, execution, and reporting.
• Communicates audit outcomes to collaborators and writes the audit report
• Assesses audit responses and ensures proposed corrective action preventative actions (CAPA) received by auditee(s) are adequate.
• Provides oversight and monitoring to ensure timely closure of all CAPAs.
• Review and approve internal and external deviations including associated root cause analysis, CAPAs, and effectiveness checks.
• Provide input and updates into the quality sections of the Pharmacovigilance System Master File.
• Perform quality control activities, as appropriate, to ensure accuracy of the data within the quality sections of the PSMF.
• Chips in to the creation and/or revision of procedural documents (i.e. Standard Operating Procedures, Work Instructions) and other PV-related documents (i.e. Joint Operating Guidelines, Quality Management Plans, Safety Data Exchange Agreements).
• Participates in Regulatory Authority inspections and assists with inspection readiness activities. Provide input, review and oversight of responses to inspection observations including any regulatory agency questions resulting from inspections.
• Proactively identify and report systematic issues.
• Lead and/or assist in operational continuous improvement initiatives to enhance processes for efficiency and effectiveness.
• Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources.

Position Requirements:

• Minimum BS degree in Chemistry, Biology or related life sciences field required with minimum 3-4 years of experience in pharmaceutical industry, 2 years of which are pharmacovigilance and/or GVP Quality Assurance.
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience.
• Requires experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
• Broad knowledge and understanding of global pharmacovigilance regulations and guidelines, including FDA, EMA and ICH regulations is required.
• Experience in leading and/or conducting internal and external audits (i.e. global PV systems, vendors/third parties, and Business Partners). Auditing certification or credentials through recognized quality standards organization is preferred.
• Knowledge of Adverse Event (AE) reporting requirements and pharmacovigilance principles.
• Knowledge of vendor management and contract management related to PV activities with business partners and external vendors such as Specialty Pharmacies, Patient Support Programs, Named Patient Programs, Market Research, and Market Access is required.
• Knowledge of adverse event reporting requirement clauses within contractual agreements such as Safety Data Exchange Agreements with business partners, and Master Service Agreements/Statement of Works with vendors/third parties (i.e. Patient Support Programs, Specialty Pharmacies) is required.
• Experience developing and reviewing procedural documents to ensure global regulatory expectations are met.
• Experience with CAPA management and issue resolution.
• Excellent communication skills, social skills and ability to work with individuals at all levels of the organization and externally.
• Confirmed skills in taking initiative and working independently
• Attention to detail and accuracy
• Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices.
• Must optimally exhibit Insmed’s five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration.

$111,000 - $156,133 a year

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 employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.