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 evaluation, signal detection, risk communication, updates on safety information, and risk mitigation strategies.

• Deliver medical and drug safety knowledge for risk-benefit evaluations, interpretation of clinical trial data, and medical assessment of individual 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 correspondence with regulatory bodies, IRBs, and Ethics Committees.

• Act as the main point of contact responsible for establishing and conducting Data Safety Monitoring Boards (DSMBs) and safety data review meetings.

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

• Conduct event coding reviews and reconciliation of clinical and safety databases.

• Manage Drug Safety systems to ensure compliance, database ownership, access, monitoring, signal detection, and reporting.

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

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

• Maintain readiness for audits and inspections.

⛳️ Requirements

• An MD is required.

• 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 focused on early clinical development.

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

• Successful participation in interactions with regulatory agencies or during inspections.

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

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

• Competence in standard computer applications, including Microsoft Office, Windows, and safety databases.

• Experience with case processing in ARGUS.

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

• Capability to challenge existing procedures and adapt to diverse situations.

• Ability to achieve quality and performance benchmarks.

• Strong influencing abilities.

• Exceptional written and verbal communication skills.

• Proficiency in working effectively as part of a team and fostering collaboration.

• Demonstrated ownership, initiative, and accountability.

• Proven ability to fulfill commitments and understand service culture.

• Effective and efficient communication regarding safety matters.

• Consistent in safety assessments.

• Ability to serve as a Drug Safety expert within cross-functional teams.

• Competence in monitoring regulatory compliance of safety reporting throughout clinical trials.

• Capacity to lead and contribute to the enhancement of Drug Safety processes.

🏝️ Benefits

• Travel required is less than 20%.

• Opportunity for remote work arrangements.

• Employment is regular and full-time.