FSP – Associate Safety Specialist
工作标题：FSP 联络安全专家职位位置：远程，印度工作地点类型：远程工作合同类型：全日制工作资深级别：工作时间表标准 （月-周五）环境条件办公室 工作描述加入我们作为联络安全专门人员创新前沿影响 我们已经成功支持了50个顶尖的药品公司和750多家生物技术，在过去5年中跨越100多个国家进行2,700次临床试验。作为我们的专业团队的一部分，你将有机会确保对患者安全产生真正差异的运营卓越性。作为安全专家，你将在严格的时间表驱动的高度监管环境中执行日常药物警 (PV) 活动。你的责任包括但不限于收集，监测，评估，评估，研究和跟踪安全信息。你将开展诸如有害事件数据输入，编码，对不利事件评估，案例审查，后续，追踪报告和监管报告的活动等活动。你将与项目团队成员，客户联系人，调查人员，负面事件记者和第三方供应商等各方有效合作。• 执行日常光伏活动。可为特定项目进行随时调试，以确保从调查场所接收病例24小时的覆盖范围。• 审查监管/药物预防措施出版物和信息来源，以便不断更新当前的规定，做法，程序和建议。保持有关适用的治疗领域和疾病的医学理解。• 对质量，一致性和准确性进行审核，包括同行报告的审查。• 编制并维护监管安全报告。教育和经验要求：• 学士学位或相当及相关正式学术/职业资格 •提供工作执行知识，技能和能力的前经验 （相比于0至2年）.在某些情况下，由适当教育，培训和/或直接相关经验结合而成的等价将被视为足够使个人能够满足职位要求。知识，技能及能力：•强有力的批判性思维和解决问题的技巧 •包括表达技能的口头和书面沟通技能 •良好的指挥能力
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Job Title: FSP – Associate Safety Specialist
Job Location: Remote, India
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as Associate Safety Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As Associate Safety Specialist, you'll perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include, but are not limited to, the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will perform activities such as adverse event data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
What You’ll Do:
- Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
- •Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease
- •states.
- •Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
- •Prepares and maintains regulatory safety reports.
- Education and Experience Requirements:
- •Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- •Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
•Strong critical thinking and problem solving skills
•Good oral and written communication skills including paraphrasing skills
•Good command of English and ability to translate information into local language where required
•Computer literate with the ability to work within multiple databases
•Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
•Understanding of medical terminology
•Understanding the importance of and compliance with procedural documents and regulations
•Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
•Strong attention to detail
•Ability to maintain a positive and professional demeanor in challenging circumstances
•Ability to work effectively within a team to attain a shared goal
Working Conditions and Environment:
•Work is performed in an office environment with exposure to electrical office equipment
•Daily exposure to high pressure and intense concentration
•Daily interactions with clients/associates
•Long, varied hours on occasion
•Travel required on occasion domestic and/or international
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
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Originally posted on Himalayas