Safet Associate

Job Description

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations 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 database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. 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. 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. 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. 100% compliance towards all people practices and processes Perform other duties as assigned. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req An Individual with a minimum of a Bachelor s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database. Beginner Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner Excellent attention to detail and accuracy. Beginner Good working knowledge of Microsoft Office and web-based applications. Beginner Strong organizational skills and time management skills. Beginner 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, manage competing priorities and deadlines. Beginner Ability to delegate to less experienced team members. Beginner Willingness and aptitude to learn new skills across Safety service lines. Beginner Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner Ensure quality of deliverables according to the agreed terms. Beginner Demonstration of IQVIA core values while doing daily tasks Beginner Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner Regular sitting for extended periods of time. Beginner May require occasional travel. Beginner Flexibility to operate in shifts. Beginner