安全医生
Safety Physician
Precision for Medicine 正在招聘一名经验丰富的药物安全医学专家加入我们的团队。候选人可位于英国、匈牙利、波兰、罗马尼亚、塞尔维亚或斯洛伐克。
职位概述：
药物安全医学专家将负责药物警戒职能，包括对所有类型安全事件的医学审查和监督处理。该职位将为公司提供药物安全数据管理与解读以及风险管理活动的临床支持，包括对临床试验严重不良事件（SAE）处理和安全数据分析的监督，以支持信号检测和风险/获益评估。该职位将确保按照 FDA、EMA 和 ICH 指南、适用的监管要求、良好临床实践（GCP）和标准操作程序（SOP）进行及时、一致和准确的安全报告。
职责（包括但不限于）：
- 管理药物安全和药物警戒的所有方面，包括安全数据审查、信号检测、风险沟通（包括安全信息更新）以及潜在风险的缓解
- 提供医学和药物安全专业知识，以基于持续的风险/获益评估、临床试验数据解读和个别病例报告的医学审查做出决策
- 与 CRO 药物安全医学专家/团队以及 Dragonfly 的医学总监、临床科学家和其他部门合作，进行安全监测、评估和报告工作（个例和汇总）
- 参与跨职能文件中的安全部分（例如，研究方案、研究报告、IBs、ICFs）以及对监管机构、IRBs 和伦理委员会的安全相关问题的回复
- 作为 DSMB 或安全数据审查会议的负责人，负责建立和运行这些会议
- 参与正在进行的 I 期剂量递增研究的安全队列常规审查
- 执行事件编码审查和临床及安全数据库的核对，以确保编码一致
- 监督和管理药物安全系统，以确保所有相关地区符合安全数据管理和报告要求，并优化安全数据库的所有权和访问权限，用于安全监测、信号检测和报告
- 确保有效的 SOP 和强大的安全供应商管理到位
- 主动建议并规划药物安全和药物警戒的未来发展，以支持快速推进
查看英文原文
Precision for Medicine is hiring an experienced Drug Safety Physician to join our team. Candidates can be based in the UK, Hungary, Poland, Romania, Serbia or Slovakia.
Position Summary:
The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).
Responsibilities (including but not limited to):
- Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
- Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs
- Work with CRO Safety Physicians/Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate)
- Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics Committees
- Act as the point of contact accountable for setting up and running 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 & safety database reconciliation for consistent coding
- Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting
- Ensure effective SOPs and strong safety vendor governance are in place
- Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
- Ensure audit and inspection readiness of the function at all times
Education and Skills Required:
- MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech
- Clinical trial experience, including oncology drug safety with least 3 years being 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 using standard computer applications (eg Microsoft Office, Windows) and safety databases
- Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information
- Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders
- Fosters strong relationships and values collaboration to develop and execute on plans
- Ability to multi-task in a fast-paced environment
- Self-motivated, conscientious, and enthusiastic about curing human diseases
Other Required:
- Experience with case processing in ARGUS
- Experience of Analysis of Similar Events (AoSE) and patient safety narratives
- Demonstrated ability to challenge existing practices to become more effective.
- Ability to effectively adapt to a variety of situations.
- Meet quality and performance standards.
- Strong influencing skills
- Excellent communication skills, both written and oral
- Work effectively as a team member and promotes collaboration.
- Demonstrate ownership, initiative and accountability.
- Less than 20% travel.
Competencies:
- Ability to deliver on commitments and understanding of service culture.
- Communicates effectively and efficiently on safety issues to internal and external stakeholders.
- Maintain consistency of safety assessments.
- Serve in cross-functional teams as Drug Safety expert.
- Monitor regulatory compliance of safety reporting throughout trial.
- Lead and contribute to process development and/or process improvements that support Drug Safety
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
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