Safety Operations Physician

Responsibilities

• 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.
• 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.
• 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.
• Partner 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.
• Communicate safety findings and recommendations to internal and external stakeholders.

Requirements

• 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.

Qualifications

• 5–8+ years of experience in pharmacovigilance or drug safety.
• 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 (if applicable).
• Prior experience in biotech or pharmaceutical industry.

Benefits

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.

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.

We 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.