Insmed Incorporated · 16 hours ago
Manager, Pharmacovigilance Quality Assurance
United States
Full-time
Remote
Mid, Senior Level
$124K/yr - $161K/yrInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Manager of Pharmacovigilance Quality Assurance will manage quality and regulatory compliance related to Good Pharmacovigilance Practices, support collaboration with internal and external teams, and ensure compliance with global standards and regulations.
BiotechnologyHealthcarePharmaceuticalMedical
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 stakeholders 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
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
Qualification
Required
Experience in Pharmacovigilance and Quality Assurance
Knowledge of Good Pharmacovigilance Practices (GVP)
Ability to conduct internal and external audits
Experience in risk assessments related to Pharmacovigilance activities
Strong communication skills for reporting audit outcomes
Experience in creating and maintaining procedural documents
Ability to participate in Regulatory Authority inspections
Experience in providing training and support to staff members
Strong analytical skills for root cause analysis and CAPA
Benefits
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
Founded in 1988
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Roger Adsett
Chief Operating Officer
Recent News
Company data provided by crunchbase