Job Application for Senior Associate, Medical Safety Operations at Mirum Pharmaceuticals

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MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

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.

JOB FUNCTIONS/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

Education/Experience:

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.

Knowledge, Skills and Abilities:

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

The salary range for this position is $146,000 to $151,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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Senior Associate, Medical Safety Operations

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