Senior Manager, Medical Safety Operations

1 day ago


Foster City, California, United States Mirum Pharmaceuticals Full time
Job Summary

The Senior Manager in Medical Safety Operations will support pharmacovigilance (PV) agreement maintenance, compliance oversight, and vendor oversight activities with respect to the individual case safety report (ICSR) processes at Mirum. This role collaborates with cross-functional teams, vendors, and partners/distributors to ensure the effective management of safety data exchange commitments.

Key Responsibilities

Develop and maintain PV agreements with license partners, distributors, and relevant parties to document safety data exchange commitments. Oversee compliance with safety data exchange commitments and ensure that PV vendor management is compliant with documented procedures and regulatory requirements. This includes ICSR quality oversight and submission compliance oversight.

Lead and address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions management related to PV processes. Conduct quarterly ICSR forecasts to ensure resources allocated by the PV vendor and internal Medical Safety staff are sufficient. Support data migration and map ICSR processes for new products as needed. Support post-market programs and audits on an as-needed basis.

Requirements

Minimum of 6 years direct pharmaceutical industry experience supporting global clinical study and post-market safety processing and reporting. 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, MD, PhD, PharmD, BSN/RN preferred. Safety database experience is required, and PV quality management experience is preferred. Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools.

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