Safety Associate
2 weeks ago
Job Overview
As a Safety Associate at IQVIA, you will play a vital role in reviewing, assessing, and processing safety data and information across various service lines. This involves receiving data from multiple sources, distributing reports and data to internal and external parties, and adhering to applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines.
Essential Functions
- To prioritize and complete assigned trainings on time.
- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
- Perform pharmacovigilance activities, including collecting and tracking incoming adverse events, determining initial/update status, database entry, AE and product coding, writing narratives, and literature-related activities.
- Ensure quality standards and productivity and delivery standards are met per project requirements.
- Comply with all project-related processes and activities.
- Read and acknowledge necessary IQVIA SOPs and customer SOPs, ensuring all required training is executed in a timely fashion and documented.
- Create, maintain, and track cases as applicable to the project plan.
- Identify quality problems and bring them to the attention of a senior team member.
- Demonstrate problem-solving capabilities.
- Liaise with functional team members, healthcare professionals, and clients to address project-related issues.
- Mentor new team members, if assigned by the manager.
- Attend project team meetings and provide feedback on challenges/issues or successes.
- Perform other duties as assigned.
Qualifications
- High School Diploma or equivalent in a scientific or healthcare discipline.
- Bachelor's degree in life sciences or a related field, with up to 3 years of relevant experience, including up to 1 year of pharmacovigilance experience.
- Good knowledge of medical terminology and working knowledge of applicable safety databases and internal/client applications.
- Knowledge of applicable global, regional, and local clinical research regulatory requirements.
- Excellent attention to detail and accuracy.
- Strong organizational skills, time management, and verbal/written communication skills.
- Self-motivated and flexible, with the ability to follow instructions, 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 and establish effective communication and working relationships with coworkers, managers, and clients.
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