Safety Operations Specialist
Descripción del trabajo
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 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.
• Ensure compliance to all project related processes and activities.
• Creating, maintaining and tracking cases as applicable to the project plan.
• 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.
• To mentor new teams members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences
• Bachelor's degree in life sciences or health care discipline and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
• Equivalent combination of education, training and experience.
• Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database and any other internal/Client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements.
• Excellent attention to detail and accuracy.
• maintain high quality standards.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational skills and time management skills.
• Strong verbal/written communication skills.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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