Safety Data Coordinator

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, Standard Operating Procedures (SOPs) and project requirements
• Perform pharmacovigilance activities, including collecting and tracking incoming adverse events, determining initial/update status of incoming events, database entry, coding adverse events and products, writing narratives, and literature-related activities
• Ensure quality standards and productivity and delivery standards 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
• Demonstrate problem-solving capabilities and mentor new team members if assigned
• Attend project team meetings and provide feedback to operations manager on challenges/issues or successes

Qualifications:

• High school diploma or equivalent in a scientific or healthcare discipline or allied life sciences
• Minimum of a bachelor's degree in a scientific or healthcare discipline or allied life sciences with 1-1.5 years of relevant experience
• Good knowledge of medical terminology
• Working knowledge of applicable safety databases
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy
• Good working knowledge of Microsoft Office and web-based applications
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Ability to multi-task, manage competing priorities and deadlines
• Ability to delegate to less experienced team members
• Willingness and aptitude to learn new skills across safety service lines
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients
• Ability to work as a team player, contribute and work towards achieving team goals
• Ensure quality of deliverables according to agreed terms
• Demonstration of IQVIA core values while doing daily tasks