Safety Scientist

Posted 2 Days Ago
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Redwood City, CA
Junior
Healthtech • Biotech
The Role
The Safety Scientist provides safety science and pharmacovigilance support for Revolution Medicines' product portfolio, overseeing clinical studies, authoring clinical trial documents, and conducting medical reviews of safety reports. They collaborate with cross-functional teams while ensuring compliance with regulations. Responsibilities also include identifying clinical safety issues and contributing to risk management activities.
Summary Generated by Built In

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for supporting clinical studies, review of clinical trial protocols, supporting updates to IBs, ICFs, and authoring of DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

The Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:

  • Proactive medical safety surveillance of ongoing clinical trials for identification of safety

  • Conduct ongoing safety data reviews; prepare and present summaries to internal stakeholders.

  • Medical review of individual case safety reports, routine review of safety data and pertinent scientific literature articles.

  • Identify potential clinical safety issues for ongoing clinical trials based on emerging safety data.

  • May perform safety reviews of relevant sections of clinical trial protocols, Investigator’s Brochures (including reference safety information), clinical study reports, informed consent forms, DSURs, and other study related documents, as required.

  • Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).

  • Conducts signal detection and evaluation activities for assigned products in collaboration with senior Safety Science team member(s) as part of the continuous benefit-risk evaluation throughout the product lifecycle.

  • Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, study sites, CROs).

  • Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

  • A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

  • 1 or more years of drug development experience in the pharmaceutical or related industry

  • Detail-oriented with ability prioritize tasks and function independently as appropriate

  • Strong learning orientation, curiosity, and commitment to science and patients

  • Excellent written and verbal communication skills.

Preferred Skills:

  • Understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management ​

  • Exposure to Safety Operations and experience with individual case review

  • Knowledge and/or experience with clinical trial management and data review

The base salary range for this full-time position is $116,000 to $145,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes the protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].

#LI-Hybrid   #LI-YG1

The Company
Redwood City, California
548 Employees
On-site Workplace
Year Founded: 2014

What We Do

We are Revolutionaries – passionate in our singular pursuit of discovering, developing and delivering innovative, targeted medicines for patients living with cancer. To deliver on our vision, we work relentlessly in pursuit of cutting-edge therapeutic approaches to some of the toughest cancers. Our current focus is on RAS-addicted cancers, which account for 30 percent of all new human cancer diagnoses

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