Safety Operations Physician

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 Medical Review Physician plays a critical role in ensuring the safety of pharmaceutical products across their lifecycle by providing medical oversight of safety data, including clinical trials and post-marketing surveillance. This role sits at the intersection of clinical safety and data analysis, translating safety information into actionable insights that protect patients and inform benefit–risk decisions.Responsibilities:Medical Review & Case AssessmentServes as a safety medical expert to evaluate Individual Case Safety Reports (ICSRs) and perform medical review of Serious Adverse Events (SAEs) from various sources, including clinical trials, literature, and post-marketing sources.Assess causality, seriousness, and expectedness of adverse events using clinical judgment and regulatory frameworks.Ensure accurate medical evaluation, coding (e.g., MedDRA), and completeness of safety data.Review case narrative and medical contents for completeness, identify missing medical information or key data that impact medical understanding and evaluation of the case, and issue safety medical queries.Review and approve the Analysis of Similar Events and provide company comments and assessment with medical analysis for SUSAR/IND Safety Reports.Provide overall case assessment and pharmacovigilance comment on ICSRs as needed.LeadershipProvide medical leadership for case review activities across Global Patient Safety, including prioritization and oversight of medically significant or complex safety cases.Serve as a key escalation point for case-level medical issues, advising Product Safety Lead Physicians, Safety Scientists, Medical Monitors, and Safety Operations partners as needed.Help shape a consistent, high-quality approach to medical review by mentoring new team members and sharing best practices in clinical assessment, causality, expectedness, and case interpretation.Lead or support training for internal teams and vendors involved in medical review activities to strengthen quality, consistency, and inspection readiness.Contribute medical expertise to cross-functional initiatives, process improvements, and governance discussions related to patient safety and pharmacovigilance operations.Act as a subject matter expert for medical review during audits, inspections, and other quality or compliance-related activities.Drive accountability and excellence in medical review by identifying trends, recommending improvements, and partnering across functions to resolve issues efficiently.Cross-functional CollaborationPartner with Clinical Development, Regulatory Affairs, Biostatistics, Safety Science, Safety Surveillance, and Safety Operations.Collaborate with Safety Science for signal detection activities and risk management planning, as required.Serve as a medical safety expert on cross-functional teams and governance forums.Communicate safety findings and recommendations to internal and external stakeholders.Compliance & QualityEnsure compliance with global pharmacovigilance regulations and guidance, including applicable FDA, EMA, ICH, and GVP requirements.Partner closely with GPS Quality to establish, implement, and continuously improve quality management system frameworks supporting medical review activities.Contribute to the development, maintenance, and periodic review of SOPs, work instructions, standards, and controlled documents governing medical review processes.Support the design and execution of quality oversight for medical review, including case-level quality review, trend analysis, issue escalation, and continuous improvement initiatives.Perform or support periodic review of adverse event line listings and other quality outputs to identify inconsistencies in event capture, coding, seriousness, expectedness, and causality assessments.Analyze quality and compliance metrics, perform root cause analyses for identified issues, and help drive corrective and preventive actions in partnership with GPS Quality and cross-functional stakeholders.Participate in inspections, audits, and inspection readiness activities, serving as a medical review subject matter expert as needed.Promote a quality-focused culture by embedding inspection readiness, documentation standards, and process discipline into day-to-day medical review operations.Required Skills, Experience and Education:MD, DO, or international equivalent.Clinical training with strong medical judgment and diagnostic skills.Experience in pharmacovigilance, drug safety, or clinical development.Knowledge of global safety regulations (ICH, GVP, FDA, EMA).Experience reviewing ICSRs and performing causality assessments.Strong clinical reasoning and ability to interpret complex safety data.Understanding of drug safety lifecycle and benefit–risk evaluation.Excellent written and verbal communication skills.Ability to work cross-functionally in a global, matrixed environment.Attention to detail, quality, and regulatory compliance.Preferred Skills:Completion of an accredited medical residency program, preferably in oncology, internal medicine, or another relevant specialty, is preferred.Experience with safety databases (e.g., Argus) and coding dictionaries (MedDRA, WHO Drug).Experience with aggregate safety reports and regulatory submissions.Oncology or relevant therapeutic area expertise.#LI-SH1 #LI-HybridThe 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.Please note that base pay salary range 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 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 View email address on us.fitly.work Pay Salary Range$261,000—$300,000 USDWe are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to View email address on us.fitly.work so we can share these impersonations with our IT team for tracking and awareness.