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Safety Operations Specialist with French language

IQVIA Holdings Inc.

Dublin, Ireland

Job Overview
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.

Main Responsibilities:
• 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

Qualifications
• 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 and French (at least C1 level) is a must
• 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.

Job posted: 1970-01-01