Job Description

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease.

Position:

We are seeking a Pharmacovigilance Medical Reviewer to support safety activities for investigational products in clinical development. This role is focused on the medical review and evaluation of individual case safety reports (ICSRs), with an emphasis on early-phase and late-phase clinical trials. The ideal candidate will also be poised to support post-marketing pharmacovigilance activities as our pipeline progresses to commercialization. The Medical Reviewer will be responsible for providing medical expertise in the evaluation and reporting of adverse events, ensuring compliance with global pharmacovigilance regulations, and contributing to the safety profile assessment of Nurix's pharmaceutical products throughout their lifecycles.

Responsibilities:

• Perform medical review of clinical trial ICSRs, ensuring timely and accurate assessment of seriousness, expectedness, and causality
• Write Analysis of Similar Events (AOSE)
• Collaborate with Safety Scientists and Clinical teams on ongoing safety surveillance, including signal detection and trend analyses
• Participate in Safety Review Committee (SRC) meetings, Data Monitoring Committees (DMCs), and safety governance meetings, as needed and provide medical input into safety-related decisions
• Analyze safety data to identify potential signals and trends requiring further investigation
• Contribute to the preparation of Development Safety Update Reports (DSURs) and Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs),
• Support expedited reporting of serious adverse events to regulatory authorities within required timelines
• Contribute to the benefit-risk assessments and assist in the development, implementation, and evaluation of risk minimization measures
• Review product labeling from a safety perspective and recommend appropriate updates
• Collaborate with cross functional teams to ensure alignment on safety-related topics
• Provide medical expertise to support responses to safety queries from regulatory authorities
• Contribute to the development of company-specific MedDRA queries for signal detection
• Serve as a safety representative in cross-functional teams and project meetings
• Provide training and oversight of external vendor to promote high quality medical review, writing concise medical queries and causality assessment
• Perform additional PV related responsibilities as delegated by supervisor

Education and Experience

• MD, PharmD, or RN degree required
• Experience supporting oncology trials
• Minimum 5 years of experience in pharmacovigilance performing medical review
• Proficient with safety databases (e.g., Argus, ARISg) and MedDRA coding
• Clinical acumen with the ability to interpret safety data and assess adverse events in context.
• Excellent communication skills and ability to collaborate cross-functionally
• Strong analytical skills with ability to interpret complex medical and scientific data
• Excellent written and verbal communication skills
• Proficiency in medical writing, particularly safety narratives and case evaluations

Personal Attributes

• Meticulous attention to detail and strong quality focus
• Ability to work effectively in fast paced setting and meet strict deadlines
• Excellent interpersonal skills with ability to collaborate across functions
• Self-motivated with capacity to work independently and as part of a team

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Job Tags

Full time,

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