Op Specialists for Regulatory Reporting team (G130/g140)
Buenos Aires, Argentina
hace 1 día

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 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.
  • 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
  • Main 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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