Job Description
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, SOPs, and internal guidelines under guidance and support of senior operation team members.
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.
4. Determine initial/update status of incoming events.
5. Database entry.
6. Coding AE and Products, writing narratives, Literature related activities as per internal/project timelines.
7. Ensure to meet quality standards per project requirements.
8. Ensure to meet productivity and delivery standards per project requirements.
9. Ensure compliance to all project-related processes and activities.
10. Create, maintain and track cases as applicable to the project plan.
11. Identify quality problems, if any, and bring them to the attention of a senior team member.
12. Demonstrate problem-solving capabilities.
13. Mentor new team members, if assigned by the Manager.
14. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
15. Ensure 100% compliance towards all people practices and processes.
16. Perform other duties as assigned.
Qualifications
1. Minimum of a bachelor’s degree in scientific or healthcare discipline or allied life sciences graduation.
2. Advanced English.
3. Basic Spanish (desirable).
4. Good knowledge of medical terminology. Intermediate.
5. Working knowledge of applicable Safety Database. Beginner.
6. Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner.
7. Excellent attention to detail and accuracy. Beginner.
8. Good working knowledge of Microsoft Office and web-based applications. Beginner.
9. Strong organizational and time management skills. Beginner.
10. Strong verbal/written communication skills. Intermediate.
11. Self-motivated and flexible. Intermediate.
12. Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate.
13. Ability to multi-task, manage competing priorities and deadlines. Beginner.
14. Ability to delegate to less experienced team members. Beginner.
15. Willingness and aptitude to learn new skills across Safety service lines. Beginner.
16. Ability to establish and maintain effective communication and working relationships with coworkers, managers, and clients. Beginner.
17. Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner.
18. Ensure quality of deliverables according to the agreed terms. Beginner.
19. Demonstration of IQVIA core values while doing daily tasks. Beginner.
20. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner.
21. Flexibility to operate in shifts. Beginner.
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 https://jobs.iqvia.com
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