Safety Operations Specialist 1
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 Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
• Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events/endpoint information, determining initial/update status of incoming events database entry, coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines
• Ensure to meet quality, productivity and delivery standards per project requirements
• Identify quality problems, if any, and bring them to the attention of a senior team member
• Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes
• At least Bachelor's degree in life sciences or related field
• Up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience
• Very good written and verbal skills in English
• Good knowledge of medical terminology and strong verbal/written communication skills
• Excellent attention to detail and accuracy
• Very good organizational skills, time management skills and problem solving capabilities
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Good working knowledge of Microsoft Office and web-based applications
• Knowledge of applicable global, regional, local clinical research regulatory requirements or applicable Safety Database and any other internal/Client applications will be an asset
• Ability to work as a Team Player, contribute and work towards achieving Team goals.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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