Safety Physician

🔥 1 minute 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 20%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 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 SAE case reports • Collaborate with CRO Safety Physicians/Team, 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 regulatory responses • Set up and run DSMBs or 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 and ensure compliance with safety data management and reporting requirements • 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 • Ensure audit and inspection readiness • Monitor regulatory compliance of safety reporting throughout trials • Lead or contribute to Drug Safety process development and improvement

🎯 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 a variety of 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 • Demonstrated ownership, initiative and accountability • Less than 20% travel

🏖️ Benefits

• Less than 20% travel • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities