Specialist, DSPV Compliance
Insmed Incorporated
12 hours ago
Remote
United States
Operations
About The Role
Specialist, DSPV Compliance on the Drug Safety & Pharmacovigilance (DSPV) team. Reporting to the Director, DSPV Compliance, responsible for ensuring pharmacovigilance activities comply with global regulations (GVP), company policies, and industry standards by supporting deliverables across document management, training, quality/compliance, and audit/inspection readiness within the Insmed Drug Safety & DSPV department.
Responsibilities
- Assist with development, review, and approval of DSPV controlled documents (SOPs, policies, templates, forms).
- Maintain team trackers, documents, and folders for accurate, organized, efficient document management.
- Schedule, document, and track Adverse Event Reporting trainings for all Insmed representatives.
- Support facilitation of DSPV training with role-specific curricula.
- Initiate, track, monitor, and follow up on non-compliance matters for Insmed and PV-related vendors.
- Support review/management of deviations, CAPAs, Quality Events, and other compliance activities (e.g., Note to Files, Storyboards).
Qualifications
- Bachelor’s degree minimum.
- At least 2 years of relevant Pharmacovigilance experience.
Skills
- Excellent Microsoft Office (Word, Excel, PowerPoint).
- Ability to manage competing deliverables and prioritize effectively.
- Problem solving; able to be coached/directed.
- Seek guidance/input when needed.
- Strong attention to quality, detail, and accuracy.
Travel/Work
- Fully remote; occasional domestic travel (~5%–10%).
Pay Range
- $42.00–53.00 hourly.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
Specialist, DSPV Compliance on the Drug Safety & Pharmacovigilance (DSPV) team. Reporting to the Director, DSPV Compliance, responsible for ensuring pharmacovigilance activities comply with global regulations (GVP), company policies, and industry standards by supporting deliverables across document management, training, quality/compliance, and audit/inspection readiness within the Insmed Drug Safety & DSPV department.
Responsibilities
- Assist with development, review, and approval of DSPV controlled documents (SOPs, policies, templates, forms).
- Maintain team trackers, documents, and folders for accurate, organized, efficient document management.
- Schedule, document, and track Adverse Event Reporting trainings for all Insmed representatives.
- Support facilitation of DSPV training with role-specific curricula.
- Initiate, track, monitor, and follow up on non-compliance matters for Insmed and PV-related vendors.
- Support review/management of deviations, CAPAs, Quality Events, and other compliance activities (e.g., Note to Files, Storyboards).
Qualifications
- Bachelor’s degree minimum.
- At least 2 years of relevant Pharmacovigilance experience.
Skills
- Excellent Microsoft Office (Word, Excel, PowerPoint).
- Ability to manage competing deliverables and prioritize effectively.
- Problem solving; able to be coached/directed.
- Seek guidance/input when needed.
- Strong attention to quality, detail, and accuracy.
Travel/Work
- Fully remote; occasional domestic travel (~5%–10%).
Pay Range
- $42.00–53.00 hourly.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.