[Hiring] Manager, Pharmacovigilance Quality Assurance @Insmed Incorporated

Role Description 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:

• Support the evaluation and acceptability of vendors, partners and other external organizations related to Pharmacovigilance (PV) activities.
• 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 including planning, execution, and reporting.
• Assess audit responses and ensure proposed corrective action preventative actions (CAPA) received by auditee(s) are adequate.
• 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.
• Contribute to the creation and/or revision of procedural documents and other PV-related documents.
• Participate in Regulatory Authority inspections and assist with inspection readiness activities.

Qualifications

• Minimum BS degree in Chemistry, Biology or related life sciences field required.
• Minimum 3 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 and post-marketing.
• Broad knowledge and understanding of global pharmacovigilance regulations and guidelines, including FDA, EMA and ICH regulations.
• Experience in leading and/or conducting internal and external audits.
• Knowledge of Adverse Event (AE) reporting requirements and pharmacovigilance principles.
• Knowledge of vendor management and contract management related to PV activities.
• 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.

Requirements

• Fully remote role; can be performed from anywhere while staying connected to the Insmed team.
• Occasional travel for team meetings or events may be expected.
• Minimal travel expected.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• 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.