Associate Director, Medical Safety Review Physician

About the role

BeOne is seeking an experienced medical professional to lead the safety review of Individual Case Safety Reports (ICSRs) across all company products, including those in clinical development and marketed. The role is fully remote and focuses on ensuring accurate, timely assessment of adverse events to support patient safety and regulatory compliance.

Key responsibilities

• Perform medical review of all ICSR sources (clinical trials, literature, post‑marketing studies, spontaneous reports).
• Determine seriousness, expectedness, and company causality for each adverse event.
• Validate MedDRA coding, seriousness criteria, and completeness of case narratives.
• Assess expectedness against Reference Safety Information and provide consistent interpretation.
• Identify missing medical information, issue safety queries, and ensure case completeness.
• Conduct company causality assessments using global methodologies and regulatory guidance.
• Review and approve analyses of similar events, including SUSAR/IND safety reports.
• Detect potential safety signals at the single‑case level and escalate critical cases to the Product Safety Lead Physician.

Required profile

• Medical degree with extensive experience in pharmaceutical/biotech safety or pharmacovigilance.
• Background in oncology or hematology preferred.
• Fluent English (written and spoken) is required.
• Demonstrated ability to work independently in a remote environment.

Required skills

• MedDRA coding and adverse event classification.
• Pharmacovigilance and safety signal detection.
• Adverse event and serious adverse event assessment.
• Case narrative review and medical content evaluation.

What we offer

• Remote work flexibility.
• Opportunity to contribute to cutting‑edge cancer research and patient safety.
• Competitive compensation package.