Safety Physician

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

📋 Description

• Oversee all facets of Drug Safety and Pharmacovigilance, which includes safety data evaluation, signal detection, risk communication, updates to safety information, and risk management strategies.

• Offer medical and drug safety expertise for risk-benefit evaluations, interpretation of clinical trial data, and medical assessments of individual SAE case reports.

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

• Contribute to the safety sections of study protocols, study reports, Investigator Brochures (IBs), Informed Consent Forms (ICFs), and communications with regulatory agencies, IRBs, and Ethics Committees.

• Organize and facilitate DSMBs or safety data review meetings.

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

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

• Manage Drug Safety systems and maintain ownership and access to safety databases.

• Ensure the implementation 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 QPPV support, Risk Management Plans, and a Pharmacovigilance System Master File.

• Maintain readiness for audits and inspections.

• Supervise regulatory compliance concerning safety reporting throughout clinical trials.

• Lead and contribute to the enhancement of Drug Safety processes.

⛳️ Requirements

• MD degree is mandatory.

• At least 7 years of experience in Drug Safety-related functions within the pharmaceutical or biotech industry.

• Clinical trial experience, particularly in oncology drug safety, with a minimum of 3 years in early clinical development.

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

• Successful participation in interactions with regulatory agencies or inspections.

• Strong understanding of FDA, EU, ICH, and other global regulatory standards for safety reporting, safety data, and risk management.

• Comprehensive medical knowledge and familiarity with medical concepts and terminology relevant to hematology/oncology clinical trials and safety monitoring.

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

• Experience with case processing in ARGUS.

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

• Willingness to travel less than 20% of the time.

• Ability to challenge current practices and adapt to various situations.

• Capability to meet quality and performance benchmarks.

• Strong influencing abilities.

• Exceptional written and verbal communication skills.

• Ability to work effectively as part of a team and encourage collaboration.

• Demonstrated ownership, initiative, and accountability in work responsibilities.

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Vacation time.

• Additional benefits.