Operations Specialist
hace 5 días
**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.**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.**Qualifications**- High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences- 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.- Strong organizational skills and time management skills.- Strong verbal/written communication skills.- Ability to follow instructions/guidelines, utilize initiative and work independently.- Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.- Willingness and aptitude to learn new skills across Safety service lines. Intermediate- Ensure quality of deliverables according to the agreed terms.- Demonstration of IQVIA core values while doing daily tasks- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.- Regular sitting for extended periods of time- Flexibility to operate in shifts.**#LI-Remote****#LI-MARIAARECHAGA
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