Junior Data Analyst (1 to 4 years experience into PV)
Responsibilities
- Triage & intake of ICSRs in ARGUS databases within agreed timelines
- Download and monitor valid ICSRs from EudraVigilance (EV)- or any other sources
- Process literature, spontaneous, clinical trial, and solicited cases
- Search for valid ICSRs in Literature search tools
- Generate reports and submit to health authorities and business partners
- Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy
- Code events, indications, patient history using MedDRA
- Code suspect products, amend narratives, and label events
- Obtain follow-up information for all cases per applicable guidelines
- Submit processed cases to regulatory authorities and distribute reports to Partners
- Communicate effectively with client stakeholders and internal teams
- Attend all internal and client trainings to ensure guideline compliance
- Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.
- Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.
- Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.
- Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations.
- Engage in rotational shifts to provide consistent support and coverage across different time zones.
Requirements
- Bachelor’s / Master’s degree in pharmacy.
- Minimum 1+ years relevant work experience in case processing activities.
- Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.
- In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs.
- Excellent organizational and time management skills.
- Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
- Good knowledge of medical terminology.
- Proven ability to follow instructions and guidelines, work independently, and take initiative.
- Excellent attention to detail and accuracy in maintaining high-quality standards.
- Strong written and verbal communication skills.
关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
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申请人可能需要通过现场面试或视频会议的方式参加面试。此外，候选人在每次面试时可能需要出示其当前所在州或政府签发的有效身份证件。
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