Specialist, DSPV Compliance

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.

Responsibilities

• Collaborate cross-functionally with internal teams and external stakeholders to achieve business objectives.
• Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms.
• Maintain relevant team trackers, documents, and folders maintaining accuracy, organization, and efficiency in document management processes.
• Support the scheduling, documentation, and tracking of all Adverse Event Reporting Trainings for all Insmed Representatives.
• Facilitate DSPV training to ensure the DSPV team receives the role-specific curricula tailored to their responsibilities.
• Aid in initiating, tracking, monitoring, and following up on non-compliance matters for Insmed and PV-Related vendors as needed.
• Review and manage deviations, CAPAs, Quality Events, and other compliance-related activities (including but not limited to Note to Files, Storyboards, etc.) as required.

Requirements

• 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.