Description
We are seeking a Safety Data Coordinator to review, assess and process safety data and information across service lines. The successful candidate will prioritize and complete assigned trainings, process safety data according to applicable regulations and guidelines, and perform pharmacovigilance activities.
Key Responsibilities:
- Prioritize and complete assigned trainings on time
- Process safety data according to applicable regulations, guidelines, and project requirements
- Perform pharmacovigilance activities, including collecting and tracking adverse events and endpoint information
- Enter data into databases, code adverse events and products, write narratives, and perform literature-related activities
- Ensure quality standards and productivity are met per project requirements
- Create, maintain, and track cases as applicable to the project plan
- Identify quality problems and bring them to the attention of senior team members
- Mentor new team members, if assigned
- Attend project team meetings and provide feedback to operations managers
Requirements:
- Bachelor's degree in Life Sciences or a related field
- Fluency in English and Spanish
- 1-2 years of pharmacovigilance experience (desirable)
- Experience with safety databases (ARGUS or others) (desirable)
- Knowledge of applicable global, regional, and local clinical research regulatory requirements (desirable)
- Excellent attention to detail and accuracy
- Good working knowledge of Microsoft Office and web-based applications
- Strong organizational and time management skills, with the ability to multitask and manage competing priorities and deadlines
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