Senior Associate, Medical Safety Operations

Role Summary

Senior Associate, Medical Safety Operations

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.

Qualifications

• 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.

Skills

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