Safety Physician (Oncology)

Location: Remote from the United Kingdom, Hungary, Poland, Romania, Serbia, or Slovakia. Less than 20% travel required.

Company

hirify.global applies biomarkers, advanced data platforms, and specialized expertise to targeted and adaptive oncology clinical trials.

What you will do

• Lead drug safety and pharmacovigilance activities, including safety data review, signal detection, risk communication, and risk mitigation.
• Provide medical oversight for clinical trial safety data, individual SAE reports, aggregate assessments, and risk-benefit evaluations.
• Collaborate with CRO safety teams, medical directors, clinical scientists, vendors, and cross-functional stakeholders.
• Contribute to safety sections of protocols, study reports, investigator brochures, informed consent forms, and regulatory responses.
• Set up and lead DSMBs and safety data review meetings, including routine reviews for Phase 1 dose-escalation studies.
• Oversee safety systems, coding review, database reconciliation, SOPs, vendor governance, QPPV support, risk management plans, and inspection readiness.

Requirements

• MD degree and at least 7 years of experience in drug safety activities within pharma or biotech.
• Clinical trial experience, including oncology drug safety and at least 3 years in early clinical development.
• Experience authoring and reviewing drug safety regulatory reports and participating in regulatory agency interactions or inspections.
• Strong knowledge of FDA, EU, ICH, and other global safety reporting and risk management requirements.
• Experience with case processing in ARGUS, Analysis of Similar Events, patient safety narratives, safety databases, and medical terminology used in hematology and oncology trials.
• Strong communication, influencing, collaboration, ownership, adaptability, and multitasking skills.

Culture & Benefits

• Remote work across the listed European countries.
• Work in a collaborative, cross-functional drug safety environment.
• Opportunity to contribute to precision oncology and targeted clinical development.
• Less than 20% travel.