Op Specialists For Regulatory Reporting Team (G130/G140) | (YEJ-445)

Op Specialists For Regulatory Reporting Team (G130/G140) | (YEJ-445)

01 jun
|
Iqvia
|
Buenos Aires C.F.

01 jun

Iqvia

Buenos Aires C.F.

Use your scientific and Pharmacovigilance expertise to join the world’s leading comprehensive pharmaceutical safety services organization on a fast-growing team performing Regulatory Reporting submissions. Apply your expertise, including GVP and/or GCP knowledge, complex decision making and working towards strict deadlines to meet legislative timelines. Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health. Job OverviewReview, 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.• 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 processesMain 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 Regulatory Reporting experience.(Or equivalent combination of education, training and experience).• Strong verbal/written communication skills, including excellent command of English.• Knowledge of applicable global, regional, local clinical research regulatory requirements.Some more:• Good knowledge of medical terminology.• Working knowledge of applicable Safety Database and any other internal/Client applications.• Excellent attention to detail and accuracy.• Strong organizational skills and time management skills.• Self-motivated and flexible.• Ability to follow instructions/guidelines, utilize initiative and work independently.• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.• Ability to delegate to less experienced team members.• Willingness and aptitude to learn new skills across Safety service lines.• Ability to work as a Team Player, contribute and work towards achieving Team goals.• Ensure quality of deliverables according to the agreed terms.• Demonstration of IQVIA core values while doing daily tasks

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