Operations Specialist 1

Job Description

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports to Regulatory Authorities, Investigative sites, and Ethical committees following applicable Regulations and Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information. determining initial/update status of incoming events. Tracking reportable cases and reporting to regulatory authorities as per legislation, within timelines and in a format compatible to requirement. Liaising with local vendors, where applicable, to facilitate expedited reporting. Liaise with different functional team members to address project related issues and successes. Receive and document incoming emails from investigative sites or other sources reporting Lifecycle Safety data. Triage of cases, generate the CTMS list, preparing alert letter package, sending SUSARs to investigators and clinical teams on time, filing the eTMF pack in ELVIS. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req Bachelor's degree in life sciences or related field and 2 years or more experience (Knowledge & Experience Required) on ICSR submission to Regulatory Authorities, Ethical Committees, and Investigative sites. Experience in Clinical Trial and Post Marketed ICSR Regulatory Reporting or any kind or Regulatory Submissions. Experience of “determining and assessing ICSR reportability to various regulatory authorities based on appropriate regulatory intelligence”. Knowledge about concepts of Clinical Trial and Post Market reporting ICH E2B should be beneficial on cross reports across licenses of a pharmaceutical product. Should have experience and knowledge of various formats of ICSR reporting that is submitted to Regulatory authorities, like xml format for EVWEB upload, E2B gateway reporting and transmission, Portal submissions, courier and manual email submissions of CIOMS, MEDWATCH. Experience in ICSR regulatory submission and regulatory guidelines for Drugs/vaccines for various countries. Knowledge of automated and manual scheduling of regulatory reports in safety database. Includes initial report, follow up regulatory report, amendment report scheduling, nullification report, downgrade report. Good knowledge of medical terminology. Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate. Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com