Specialist, DSPV Compliance
About The Position
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: We’re looking for a Specialist, DSPV Compliance on the Drug Safety & Pharmacovigilance (DSPV) team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, DSPV Compliance, you’ll be 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 DSPV Department at Insmed.
Requirements
- A minimum of a Bachelor’s degree
- 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.
Responsibilities
- Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms.
- 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
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- 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
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
