Associate Director, Medical Safety Science (Safety Scientist)

Mirum Pharmaceuticals•Foster City, CA

2d•$215,000 - $230,000•Hybrid

About The Position

Mirum Pharmaceuticals 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.

Requirements

Bachelor’s degree in a scientific discipline is required.
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.
Experience as an SME for Safety Science in audits and inspections
Excellent interpersonal and communication skills, both written and oral
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

Nice To Haves

RN, MS (Master of Science) or PharmD degree is highly desired (coursework in clinical research preferred).
MSSO-trained and UMC trained preferred
Safety database and data entry experience preferred (Understands safety database structures and is familiar with data retrieval tools.)
Understanding of medical terminology and the ability to summarize medical information is preferred

Responsibilities

Conduct Sponsor oversight from a safety science perspective, and assessment of ICSRs 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