Manager, Pharmacovigilance Quality Assurance

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:
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.

What You'll Do:

In this role, you'll have the opportunity to 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.

You will also:

• Conduct and/or assist with the completion and evaluation of supplier pre-qualification surveys.
• Create and maintain 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.
• Communicate audit outcomes to stakeholders and writes the audit report.
• Assess audit responses and ensure 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.
• Contributes 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.

Who You Are:

You have minimum BS degree in Chemistry, Biology or related life sciences field required with minimum 3 years of experience in pharmaceutical industry, 2 years of which are pharmacovigilance and/or GVP Quality Assurance. You'll also have:

• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience.
• Requires experience with pharmacovigilance in Phases I-IV and post-marketing (particularly).
• 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.
• Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices.

Pay Range:
$124,000.00-161,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [email protected] 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.