3 Adverse Events Jobs

Job Responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. - Enters data into safety database. - Codes events, medical history, concomitant medications, and tests. - Compiles complete narrative summaries. - Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. - Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. - Maintains safety tracking for assigned activities. - Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. - Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. - Manual recoding of un-recoded product and substance terms arises from ICSRs. - Identification and management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. - Fosters constructive and professional working relationships with all project team members, internal and external. - Participates in audits as required/appropriate. - Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Irillic Software QA Engineer We are seeking a highly skilled and experienced Software QA Engineer to join our team. The successful candidate will be responsible for ensuring the quality of our software products by designing and executing comprehensive test plans and test cases. This role requires close collaboration with the development team to identify and resolve issues, ensuring the delivery of high-quality products that meet client needs. Responsibilities Automated Test Case Design: Develop detailed, comprehensive, and well-structured automated test cases for use by QA and development teams, covering various aspects of software functionality. Test Planning: Develop test plans, test cases, and other documents as per quality procedures to ensure thorough testing and validation. Collaboration with Development Team: Work closely with the development team to ensure the effectiveness and quality of the components and systems developed. QA Process Adherence:: Coordinate the compiling and control of quality assurance documents with representatives from other internal departments. Adverse Event Investigation and Reporting: Investigate, maintain, and report adverse events and product issues as part of Corrective Action and Preventive Action (CAPA) Requirements and Skills Proven Experience: 2+ years of experience in software quality assurance, with a strong background in manual testing and test planning. Technical Skills: Proficiency in implementing end-to-end solutions for unit, regression and integration testing for software development. Communication and Collaboration: Excellent analytical, communication, time management, and problem-solving skills, with the ability to work effectively with cross-functional teams with industrial quality tooling softwares such as JIRA, Confluence. Education: Bachelor's or Master's degree in Computer Science, Engineering, or a related field. Good To Have Knowledge of medical quality standards for software (i.e IEC 62304, ISO 60601) Working Proficiency with C++ What We Offer Competitive salary and benefits package Opportunities for professional growth and development Collaborative and dynamic work environment If you are a motivated and detail-oriented individual with a passion for ensuring software quality, we encourage you to apply for this exciting opportunity

As a Clinical Research Associate (CRA), you will play a key role in conducting Phase I-IV clinical BA/BE studies. Your primary responsibilities will involve monitoring and managing activities at clinical sites to ensure that project timelines and deliverables are achieved. Building strong relationships with clinical sites and investigators will be essential, along with assessing protocol and regulatory compliance based on local and federal requirements, ICH GCP guidelines, and PSI SOPs. Your focus will be on safeguarding subjects" rights, safety, and well-being, as well as maintaining data quality. Your tasks will include preparing, conducting, and reporting on various activities such as site selection, initiation, routine monitoring, and close-out visits. Monitoring patient enrollment to meet recruitment targets and project timelines will be crucial at both site and country levels. You will be responsible for source data verification, resolving data queries, and conducting ongoing reviews to ensure data quality and compliance with Risk Based Monitoring practices. Timely reporting and follow-up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations will also be part of your duties. Acting as the main communication channel between the Sponsor and the site, you will serve as a point of contact for in-house support services and vendors. Proper handling, accountability, and reconciliation of Investigational Product(s) and study supplies will be under your supervision. Additionally, you will review essential documents at the site level and ensure the reconciliation of study OSF/TMF at the site and/or country level.,