Safety Operations Physician

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

• 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.

Leadership

• 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.

Cross-functional Collaboration

• 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.

Compliance & Quality

• 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.

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:

• 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.

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