Safety Operations Physician

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 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 Assessment

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Serves 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.

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Assess causality, seriousness, and expectedness of adverse events using clinical judgment and regulatory frameworks.

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Ensure accurate medical evaluation, coding (e.g., MedDRA), and completeness of safety data.

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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.

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Review and approve the Analysis of Similar Events and provide company comments and assessment with medical analysis for SUSAR/IND Safety Reports.

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Provide overall case assessment and pharmacovigilance comment on ICSRs as needed.

Leadership

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Provide medical leadership for case review activities across Global Patient Safety, including prioritization and oversight of medically significant or complex safety cases.

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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.

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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.

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Lead or support training for internal teams and vendors involved in medical review activities to strengthen quality, consistency, and inspection readiness.

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Contribute medical expertise to cross-functional initiatives, process improvements, and governance discussions related to patient safety and pharmacovigilance operations.

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Act as a subject matter expert for medical review during audits, inspections, and other quality or compliance-related activities.

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Drive accountability and excellence in medical review by identifying trends, recommending improvements, and partnering across functions to resolve issues efficiently.

Cross-functional Collaboration

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Partner with Clinical Development, Regulatory Affairs, Biostatistics, Safety Science, Safety Surveillance, and Safety Operations.

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Collaborate with Safety Science for signal detection activities and risk management planning, as required.

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Serve as a medical safety expert on cross-functional teams and governance forums.

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Communicate safety findings and recommendations to internal and external stakeholders.

Compliance & Quality

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Ensure compliance with global pharmacovigilance regulations and guidance, including applicable FDA, EMA, ICH, and GVP requirements.

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Partner closely with GPS Quality to establish, implement, and continuously improve quality management system frameworks supporting medical review activities.

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Contribute to the development, maintenance, and periodic review of SOPs, work instructions, standards, and controlled documents governing medical review processes.

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Support the design and execution of quality oversight for medical review, including case-level quality review, trend analysis, issue escalation, and continuous improvement initiatives.

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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.

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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.

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Participate in inspections, audits, and in

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