Safety Physician

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Oversee all facets of Drug Safety and Pharmacovigilance, which encompasses safety data assessment, signal detection, risk communication, updates on safety information, and risk mitigation strategies.

• Offer medical and drug safety expertise for risk-benefit evaluations, interpretation of clinical trial data, and medical reviews of Serious Adverse Event (SAE) case reports.

• Collaborate with CRO Safety Physicians/Teams, Medical Directors, Clinical Scientists, and other departments on safety monitoring, evaluation, and reporting.

• Contribute to the safety sections of study protocols, reports, investigator brochures, informed consent documents, and responses to regulatory inquiries.

• Organize and facilitate Data Safety Monitoring Boards (DSMBs) or safety data review meetings.

• Engage in routine safety cohort evaluations for ongoing Phase 1 dose-escalation trials.

• Conduct event coding reviews and reconcile clinical and safety databases.

• Supervise Drug Safety systems to ensure adherence to safety data management and reporting standards.

• Ensure the establishment of effective Standard Operating Procedures (SOPs) and governance of safety vendors.

• Strategize future developments in Drug Safety and Pharmacovigilance for regulatory submissions and commercialization, including support for Qualified Person for Pharmacovigilance (QPPV), Risk Management Plans, and a Pharmacovigilance System Master File.

• Maintain readiness for audits and inspections.

• Oversee compliance with safety reporting regulations throughout clinical trials.

• Lead or assist in the enhancement and development of Drug Safety processes.

⛳️ Requirements

• MD degree is mandatory.

• A minimum of 7 years of experience in Drug Safety-related roles within the pharmaceutical or biotechnology sectors.

• Clinical trial experience, particularly in oncology drug safety, with at least 3 years in early clinical development.

• Proven experience in authoring, reviewing, and providing insights for drug safety-related regulatory reports.

• Successful participation in interactions or inspections with regulatory agencies.

• In-depth knowledge of FDA, EU, ICH, and other international regulatory standards for safety reporting and risk management.

• Strong medical knowledge and familiarity with the terminology and concepts used in hematology/oncology clinical trials and safety monitoring.

• Proficient in standard office software, including Microsoft Office and Windows, as well as safety databases.

• Experience with case processing in ARGUS.

• Familiarity with Analysis of Similar Events (AoSE) and patient safety narratives.

• Capability to challenge current practices and adapt to various circumstances.

• Ability to meet performance and quality benchmarks.

• Strong influencing abilities.

• Exceptional written and verbal communication skills.

• Ability to work efficiently as part of a team and foster collaboration.

• Demonstrated sense of ownership, initiative, and accountability.

• Travel required is less than 20%.

🏝️ Benefits

• Travel required is less than 20%.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.