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.
Responsibilities:
- Review, assess, and process safety data and information across service lines
- 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, determining initial/update status of incoming events, database entry, coding, and writing narratives
- Ensure quality standards and productivity are met per project requirements
- 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 manager
Qualifications:
- High school diploma or equivalent in a scientific or healthcare discipline
- Bachelor's degree in a scientific or healthcare discipline with 1-1.5 years of relevant experience
- Good knowledge of medical terminology
- Working knowledge of applicable safety databases
- Knowledge of global, regional, and local clinical research regulatory requirements
- Excellent attention to detail and accuracy
- Good working knowledge of Microsoft Office and web-based applications
- Strong organizational and time management skills
- Strong verbal and written communication skills
- Self-motivated and flexible
- Ability to follow instructions, utilize initiative, and work independently
- Ability to multi-task, manage competing priorities, and deadlines
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