Associate Director, Medical Safety Science

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

Mirum Pharmaceutical is seeking an Associate Director of Medical Safety Science. The ideal candidate will have experience performing activities related to ICSR medical review, evaluation of safety data, signal detection and validation, authoring of aggregate reports and assessment of Safety risks. The successful candidate 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
• 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
• Represent Medical Safety Science in clinical study team meetings for the assigned Mirum products
• Review and develop Medical Safety Science SOPs and Work Instructions.
• Contribute to the development of risk management plans and REMs as needed.
• Support safety surveillance/pharmacovigilance activities such as signal detection and validation, Safety Review Team meetings (SRT), and Global Safety Committee (GSC) meetings. This includes Signal monitoring/ tracking, scheduling of SRT and GST meetings, drafting of signal detection reports.
• 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, RN, or PharmD 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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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.