[Remote] Manager, Pharmacovigilance Quality Assurance

Note: The job is a remote job and is open to candidates in USA. Insmed 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.

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

Skills

• 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 Overview

• 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. It was founded in 1988, and is headquartered in Bridgewater, New Jersey, USA, with a workforce of 1001-5000 employees. Its website is http://www.insmed.com.

Company H1B Sponsorship

• Insmed Incorporated has a track record of offering H1B sponsorships, with 20 in 2025, 6 in 2024, 14 in 2023, 8 in 2022, 1 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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