Senior Manager, Medical Safety Science

POSITION SUMMARY

Mirum Pharmaceutical is seeking a Sr. Manager of Medical Safety Science. The ideal candidate will have experience in and perform multiple activities related to ICSR sponsor review, safety data review, document review, signal detection and validation, review 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, sponsor review 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.
• Shepherds Requests for Information (RFIs) forms for cross-functional teams pertaining to aggregate reports and signal detection activities.
• Review/ revise SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective.
• Works closely with Medical Safety Operations to provide medical 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 5 years in pharmaceutical or CRO experience in a clinical trial or post-marketing setting; 3 years in a drug safety and pharmacovigilance role (specifically, safety science role).
• Experience in sponsor review of ICSRs from a medical safety science perspective and safety surveillance activities (which includes but not limited to signal detection activities) is preferred.
• Experience in facilitating safety surveillance activities (including but not limited to Signal Detection and Management).
• Experience/ Knowledge of different types of safety aggregate reports (PADER, DSUR, PSUR/PBRER etc).
• Experience in PV audits and inspections.
• Familiarity with clinical documents such as ICFs, protocols, investigator’s brochure, etc.
• Experience in AE and medical history coding review is required. MSSO-trained and UMC trained preferred.
• Safety database and data entry experience required (Understands safety database structures and is familiar with data retrieval tools).

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.
• Work within a matrix environment and interact/communicate effectively across various levels within the organization when needed.
• Team player but can work independently.

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