Safety Associate

hace 3 semanas

Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

Job Overview

We are seeking a detail-oriented professional to review, assess, and process safety data and information across various service lines. This role involves receiving data from multiple sources and distributing reports to both internal and external stakeholders. You will ensure compliance with applicable regulations, SOPs, and internal guidelines, all under the guidance and support of our senior operations team.

Essential Functions

  1. Prioritize and complete the assigned trainings on time.
  2. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  3. 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.
  4. Ensure to meet quality standards per project requirements.
  5. Ensure to meet productivity and delivery standards per project requirements.
  6. Ensure compliance to all project related processes and activities.
  7. Create, maintain and track cases as applicable to the project plan.
  8. Identify quality problems, if any, and bring them to the attention of a senior team member.
  9. Demonstrate problem-solving capabilities.
  10. Mentor new team members, if assigned by the Manager.
  11. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
  12. 100% compliance towards all people practices and processes.
  13. Perform other duties as assigned.

Qualifications

  1. High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences.
  2. Minimum of a Bachelor's Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience.
  3. Good knowledge of medical terminology.
  4. Working knowledge of applicable Safety Database.
  5. Knowledge of applicable global, regional, local clinical research regulatory requirements.
  6. Excellent attention to detail and accuracy.
  7. Good working knowledge of Microsoft Office and web-based applications.
  8. Strong organizational skills and time management skills.
  9. Self-motivated and flexible.
  10. Ability to follow instructions/guidelines, utilize initiative and work independently.
  11. Ability to multi-task, manage competing priorities and deadlines.
  12. Ability to delegate to less experienced team members.
  13. Willingness and aptitude to learn new skills across Safety service lines.
  14. Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.
  15. Ability to work as a Team Player, contribute and work towards achieving Team goals.
  16. Ensure quality of deliverables according to the agreed terms.
  17. Demonstration of IQVIA core values while doing daily tasks.
  18. Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  19. Regular sitting for extended periods of time.
  20. May require occasional travel.
  21. Flexibility to operate in shifts.

This is a remote/WFH position.

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