Senior Associate, Medical Safety Operations

Role Summary

Senior Associate, Medical Safety Operations. Support vendor oversight activities related to the ICSR management process at Mirum.

Responsibilities

• Perform routine retrospective quality review of safety data to ensure completeness and accuracy; collaborate with PV vendor to address case corrections and trends.
• Provide case processing guidance to the PV vendor in alignment with Mirum standards.
• Review case metrics to ensure timely processing and exchange by the PV vendor.
• Oversee and support reconciliation of safety data from various sources.
• Oversee submission of expedited safety reports by the PV vendor and CROs; escalate and document late regulatory authority submissions.
• Generate listings from Safety Database (Argus) or OBIEE as needed.
• Collaborate across departments (Quality Assurance, Clinical Operations, Regulatory Affairs) to obtain additional information as needed by PV vendor.
• Manage and/or support system access (e.g., EDC, Argus) with periodic review of user access.

Qualifications

Education/Experience

• Minimum of 3 years of direct pharmaceutical industry experience with global clinical study ICSR processing and reporting preferred; post-approval safety experience highly desired.
• Detailed knowledge of US, EU, and ICH guidelines governing clinical studies and post-approval safety.

Knowledge, Skills And Abilities

• Bachelor‚Äôs degree in life sciences.
• Safety database experience is required.
• Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools.