Senior Associate, Medical Safety Operations

Mirum Pharmaceuticals • Foster City, CA

96d • $146,000 - $151,000 • Hybrid

About The Position

The Senior Drug Safety Associate in Medical Safety Operations will support vendor oversight activities with respect to the individual case safety report (ICSR) management process at Mirum. This role is crucial in ensuring the safety data collected is accurate and complete, and involves collaboration with various departments and external vendors.

Requirements

• Minimum of 3 years direct pharmaceutical industry experience dealing with global clinical study individual case safety report processing and reporting preferred; post-approval safety experience highly desired.
• Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
• Bachelor's degree in life sciences.
• Safety database experience is required.
• Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools.

Responsibilities

• Perform routine retrospective quality review of the safety data collected to ensure completeness and accuracy.
• Collaborate with the pharmacovigilance (PV) vendor to address case corrections and trends.
• Provide case processing guidance to the PV vendor in alignment with existing Mirum standards.
• Review case metrics to ensure cases processed by the PV vendor are processed and exchanged within the agreed upon timelines.
• Oversee and support reconciliation of safety data from various sources.
• Oversee submission of expedited safety reports by the PV vendor and clinical contract research organizations; escalate and document late regulatory authority submissions.
• Generate listing from Safety Database (Argus) or OBIEE as needed.
• Responsible for interdepartmental collaboration, such as, but not limited to Quality Assurance, Clinical Operations, Regulatory Affairs on obtaining additional information as needed by PV vendor.
• Manage and/or support system access (e.g. EDC, Argus etc.) along with periodic review of user access.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees