Safety Physician

🔥 0 minutes ago

🌐 United Kingdom, Hungary, +4 more countries – Remote

🇬🇧 United Kingdom – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Manage all aspects of Drug Safety and Pharmacovigilance, including safety data review, signal detection, risk communication, safety information updates, and risk mitigation • Provide medical and drug safety expertise for risk-benefit assessment, clinical trial data interpretation, and medical review of individual SAE case reports • Collaborate with CRO Safety Physicians/Teams, Medical Directors, Clinical Scientists, and other functions on safety monitoring, assessment, and reporting • Contribute to safety sections of study protocols, study reports, investigator brochures, informed consent forms, and responses to regulatory agencies, IRBs, and Ethics Committees • Serve as accountable point of contact for setting up and running DSMBs and safety data review meetings • Participate in routine safety cohort reviews for ongoing Phase 1 dose-escalation studies • Perform event coding review and clinical and safety database reconciliation • Oversee Drug Safety systems for compliance, database ownership, access, monitoring, signal detection, and reporting • Ensure effective SOPs and safety vendor governance • Plan future Drug Safety and Pharmacovigilance development for regulatory filings and commercialization, including QPPV support, Risk Management Plans, and a Pharmacovigilance System Master File • Maintain audit and inspection readiness

🎯 Requirements

• MD required • Minimum of 7 years in Drug Safety related activities in pharma/biotech • Clinical trial experience, including oncology drug safety, with at least 3 years in early clinical development • Experience authoring, reviewing, and providing input to drug-safety related regulatory reports • Successful involvement in regulatory agency interactions or inspections • Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management • Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring • Proficiency with standard computer applications, including Microsoft Office and Windows, and safety databases • Experience with case processing in ARGUS • Experience with Analysis of Similar Events (AoSE) and patient safety narratives • Ability to challenge existing practices and adapt to varied situations • Ability to meet quality and performance standards • Strong influencing skills • Excellent written and oral communication skills • Ability to work effectively as a team member and promote collaboration • Ownership, initiative, and accountability • Ability to deliver on commitments and understand service culture • Ability to communicate effectively and efficiently on safety issues • Ability to maintain consistency of safety assessments • Ability to serve in cross-functional teams as a Drug Safety expert • Ability to monitor regulatory compliance of safety reporting throughout trials • Ability to lead and contribute to Drug Safety process development and improvements

🏖️ Benefits

• Less than 20% travel • Remote work arrangement • Regular full-time employment