Associate Director, Medical Safety Review

POSITION SUMMARY

Mirum Pharmaceutical is seeking an Associate Director of Medical Safety Review. The ideal candidate will have experience performing activities related to ICSR medical review, evaluation of safety data, signal detection and preparation of aggregate reports. This role will report to the Director of Medical Safety Science

JOB FUNCTIONS/RESPONSIBILITIES

• Conduct medical review of ICSRs from any source including, but not limited to, clinical trials, literature, and post marketing reports
• Confirm that events are correctly coded per MedDRA conventions.
• Review case narrative and medical content for completeness, identifying missing information that may impact medical understanding of the case, reviewing queries proposed by the Safety vendor, and issuing additional safety medical queries as needed.
• Review and approve Analysis of Similar Events (AOSE)
• Provide overall case assessment and quality feedback to Safety vendor as part of sponsor oversight.
• Contribute to training, oversight monitoring, performance metrics review of Safety vendor activities where applicable.
• Support Safety Operations activities providing input on coding for SAE reconciliation, and other case processing questions from the medical review perspective.
• Generate outputs from the Safety Database for aggregate reports and ad hoc requests
• Perform coding review of adverse events and medical history in the clinical database for all Mirum products and studies
• Support the authoring of aggregate safety reports such as DSUR, PADER, PBRER, etc.
• Review medical safety science-related sections in clinical and Regulatory documents.
• Review SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective.
• Review and assess literature search results
• Supports activities related to PV-specific audit and inspection readiness

QUALIFICATIONS

Education/Experience:

• MD or RN degree with at least 5 years of pharmaceutical or CRO experience in clinical trial and post-marketing settings in a drug safety and pharmacovigilance role.
• Experience in medical review of ICSRs in clinical trial and post-marketing settings, including authoring of company comments and AOSE.
• Experience in MedDRA AE and medical history coding review is required.
• Working knowledge of the Safety and Clinical databases
• Experience in the preparation of aggregate reports, Risk Management and Minimization programs
• Experience in the preparation of safety aggregate reports
• Experience in rare diseases is a plus.

Knowledge, Skills and Abilities: 

• Excellent interpersonal and communication skills, both written and oral.
• Understanding of medical terminology and the ability to summarize medical information is preferred.
• Attention to detail and good organizational skills.
• The ability to assess data and understand the medical/safety implications.
• Team player but can work independently.
• Excellent working knowledge of pharmacovigilance and regulatory guidelines/ guidance.
• Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis

Travel: Less than 10%

The salary range for this position is $210,000 to $225,000 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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