Specialist, Drug Safety & Pharmacovigilance Compliance

Insmed Incorporated

15d • $42 - $53

About The Position

The Specialist DSPV Compliance is responsible for ensuring that pharmacovigilance activities are compliant with global pharmacovigilance regulations (i.e. GVP, Good Pharmacovigilance Practices), company policies, and industry standards by assisting with and supporting pharmacovigilance activities and deliverables related to document management, training, quality and compliance, and audit and inspection readiness within the scope of the Drug Safety and Pharmacovigilance (DSPV) Department at Insmed.

Requirements

• You have a minimum of a Bachelor’s degree as well as at least 2 years of relevant Pharmacovigilance experience.
• Excellent Microsoft Office (Word, Excel, PowerPoint) experience.
• Proven ability to manage competing deliverables while prioritizing time effectively based on project needs.
• Problem solving and the ability to be coached and directed by other teammates and partners.
• Ability to seek guidance/input from others when faced with a difficult situation.
• Attention to quality, detail, and accuracy.
• Up to 10% travel based on company requirements.

Responsibilities

• Proactively identify and implement opportunities for process optimization and efficiency improvements.
• Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms.
• Assist with electronic archival and maintenance of DSPV controlled documents
• Support the maintenance of relevant team trackers, documents, and folders maintaining accuracy, organization and efficiency in document management processes.
• Assist with the scheduling, documentation, and tracking of all Adverse Event Reporting Trainings for all Insmed Representatives.
• Support the facilitation of DSPV training to ensure the DSPV team receives the role-specific curricula tailored to their responsibilities.
• Assist in initiating, tracking, monitoring, and following up on non-compliance matters for Insmed and PV-Related vendors as needed.
• Support the review and management of deviations, CAPAs, Quality Events, and other compliance-related activities (including but not limited to Note to Files, Storyboards, etc.) as required.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level