Operations Specialist 1

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 Standard Operating Procedures SOPs and internal guidelines under guidance and support of senior operation team members Japanese linguistic role - JLPT N3 NAT Q3 certification is a must 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 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 In addition to the above mentioned responsibilities depending on the project requirement the team member may perform medical review of non-serious adverse events AEs and non-serious adverse drug reactions ADRs which includes reviewal of AE coding past medical history concomitant medications expectedness listedness causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines SOPs project-specific guidelines and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications 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 up to 3 years of relevant experience inclusive of up to 1 year of Pharmacovigilance experience Req or equivalent combination of education training and experience Pref Good knowledge of medical terminology Intermediate 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