Senior Safety Scientist I

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines, Inc. is seeking a Senior Safety Scientist I to provide safety science and pharmacovigilance support across the RevMed portfolio.

You will oversee safety for clinical studies, review protocols, IBs, ICFs, and DSURs, and participate in cross-functional teams to manage risk and ensure regulatory compliance. You will develop a strong safety profile understanding, perform signal detection, and contribute to regulatory filings while collaborating with study teams and external

Qualifications

• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline).
• 3+ years of drug development experience with at least 1 year in drug safety.
• Proven success in creating and sustaining strong relationships with internal and external partners.
• Broad understanding of safety science, PV (GVP, GCP), and risk management.
• Ability to lead and influence in a fast-paced environment.
• Strong presentation skills and ability to summarize key considerations.
• Excellent written and verbal communication.
• Therapeutic area experience in oncology.

Responsibilities

• Proactive medical safety surveillance of ongoing clinical trials and management of safety signals.
• Prepare and present safety data summaries to stakeholders.
• Medical review of ICSRs, routine safety data review, and literature reviews.
• Contribute knowledge of relevant drug class and safety issues.
• Identify potential clinical safety issues and recommend risk mitigation.
• Contribute to sections of protocols, IBs, ICFs, DSURs, and labeling.
• Ensure safety components of study reports, publications, and regulatory documents.
• Lead signal detection and evaluation for lifecycle risk/benefit assessment.
• Support regulatory filings and safety queries from agencies.
• Collaborate with study teams, CROs, investigators, and vendors.

Skills

Safety Science

Pharmacovigilance

GVP/GCP knowledge

Relationship building

Clinical trial safety

Leadership

Communication

Oncology

Education

Postgraduate Life Sciences

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

The Senior Safety Scientist I 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 safety oversight of clinical studies, review and authoring of clinical trial protocols, IBs, ICFs, and 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 Senior Safety Scientist I 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 and management of safety signals.
• Prepare and present safety data summaries to internal and external stakeholders.
• Risk management activities include, but are not limited to medical review of individual case safety reports (ICSRs), routine review of safety data and pertinent scientific literature articles.
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
• Identify potential clinical safety issues and recommend appropriate risk mitigation measures.
• Involvement in preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.
• Perform safety review of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
• Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents.
• Conducts signal detection and evaluation activities for assigned products for the continuous benefit-risk evaluation throughout the product lifecycle and contributes/leads preparation for escalation to safety governance committees.
• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.
• Contributes to input related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
• Establish and maintain collaborative working relationships with all key stakeholders (study team members, CROs, investigators, study sites, vendors, committees, etc.).
• 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).
• 3 or more years of drug development experience in the pharmaceutical or related industry with at least 1 year in drug safety.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management and safety operations.
• Demonstrated ability to lead and influence, with and without authority, in a fast-paced environment.
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Detail-oriented with ability prioritize tasks and function independently as appropriate.
• Strong organizational skills and an ability to interpret, discuss, and report trial level data effectively and identify trends.
• Excellent written and verbal communication skills.

Preferred Skills:

• Independent leadership of drug safety activities for clinical programs, including signal evaluation and benefit–risk assessment.
• Experience authoring and reviewing key safety documents (e.g., DSURs, IB updates, protocol/CSR safety sections).
• Proven ability to represent safety on cross-functional teams.
• Demonstrated scientific judgment with the ability to operate autonomously in a fast-paced environment.
• Exposure to global development programs and regulatory safety expectations.
• Experience improving PV processes or implementing new safety tools or technologies.
• Therapeutic area experience in oncology.

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

Base Pay Salary Range

$164,000 - $205,000 USD

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.

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