Safety Physician

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

📋 Description

• Oversee all elements of Drug Safety and Pharmacovigilance, encompassing safety data analysis, signal detection, risk communication, updates to safety information, and risk mitigation strategies.

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

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

• Contribute to the safety components of study protocols, study reports, Investigator Brochures (IBs), and Informed Consent Forms (ICFs), as well as address safety-related inquiries from regulatory bodies, Institutional Review Boards (IRBs), and Ethics Committees.

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

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

• Conduct review of event coding and ensure reconciliation of clinical and safety databases.

• Supervise Drug Safety systems and ensure compliance with safety data management and reporting obligations.

• Develop and implement effective Standard Operating Procedures (SOPs) and maintain strong governance over safety vendors.

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

• Ensure readiness for audits and inspections.

• Monitor adherence to regulatory safety reporting requirements throughout trial phases.

• Lead and enhance the development and improvement of Drug Safety processes.

⛳️ Requirements

• MD is required.

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

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

• Experience in authoring, reviewing, and providing insights for drug safety-related regulatory documentation.

• Successful track record of involvement in interactions with regulatory agencies or inspections.

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

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

• Proficient with standard computer applications, including Microsoft Office, Windows, and safety databases.

• Experience with case processing in ARGUS.

• Familiarity with analyzing Similar Events (AoSE) and drafting patient safety narratives.

• Proven ability to challenge current practices to enhance effectiveness.

• Capability to adapt well to diverse situations.

• Commitment to meeting quality and performance benchmarks.

• Strong influencing capabilities.

• Excellent written and verbal communication skills.

• Ability to work collaboratively as a team member and foster teamwork.

• Demonstrate ownership, initiative, and accountability.

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

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Paid vacation.

• Additional benefits.