Safety Operations Physician

Revolution Medicines•Redwood City, CA

12d•Onsite

About The Position

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.

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.

Nice To Haves

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.

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.
Provide 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.
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.
Serve as a medical safety expert on cross-functional teams and governance forums.
Communicate safety findings and recommendations to internal and external stakeholders.
Ensure 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.