Associate Director, Medical Safety Science (Safety Scientist)

Job description

Associate Director, Medical Safety Science (Safety Scientist)

Foster City

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 (Safety Scientist). The ideal candidate will have experience in and perform multiple activities related to safety data review, document review, signal detection and management, authoring of aggregate reports and participating in multidisciplinary meetings. Successful candidate will report to Sr. Director, Medical Safety.

Job Functions/Responsibilities

Conduct Sponsor oversight from a safety science perspective, and assessment of ICSPs both in post-marketing and clinical trial setting

Generate outputs from the Safety Database as needed 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

Facilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etc

Represent Medical Safety Science in assigned clinical study team meetings for Mirum products

Support the Sr. Director of Medical Safety in Safety Adjudication Meetings, as necessary

Review and develop Medical Safety Science SOPs and Work Instructions

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, reviewing of meeting slides and signal detection reports

Review and revise medical safety science-related sections in study protocols, ICFs, and periodic reports

Review Safety-related documents such as Joint Operating Guidelines, Monthly Reports

Performs vendor training for new products and/ or studies

Maintains expectedness trackers for RSIs/ labels

Maintain Safety templates such as targeted questionnaires or protocol safety reporting language

Review/ revise SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective

Works closely with Medical Safety Operations to provide scientific input on an as needed basis

Review and assess literature search results

Supports activities related to PV-specific inspection readiness by creating procedures and processes for Safety Science activities and participate in audits/inspections as the Safety Science SME

Qualifications

Education / Experience

Bachelor’s degree in a scientific discipline is required. RN, MS (Master of Science) or PharmD degree is highly desired (coursework in clinical research preferred).

Minimum 7 years in pharmaceutical or CRO experience in clinical trial or post-market setting, 5 years in a drug safety and pharmacovigilance role (specifically, as a Safety Scientist)

Experience in safety surveillance activities (which includes but not limited to signal detection activities) is a must

Experience in authoring aggregate reports such as the DSUR, PSUR/ PBRER, PADER etc.

Experience in AE and medical history coding review is required. MSSO-trained and UMC trained preferred

Safety database and data entry experience preferred (Understands safety database structures and is familiar with data retrieval tools.)

Experience as an SME for Safety Science in audits and inspections

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, critical thinking, and good organizational skills

The ability to assess data and understand the medical/safety implications

Work within a matrix environment and interact/communicate effectively across various levels within the organization when needed

Team player but can work independently

Salary

The salary range for this position is $215,000 to $230,000 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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Equal Employment Opportunity

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Mirum Pharmaceuticals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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Worksite address

foster city, CA, 94420, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.