Medical Information / Pharmacovigilance Specialist *Nordic Languages Required*
- Experience Level
- Entry level
Use your scientific and foreign language expertise to join the world’s leading comprehensive pharmaceutical safety services organization at on a fast-growing team performing medical information call center services. Apply your knowledge and expertise, including complex decision making, to review, assess and process safety and product quality information. Be a part of a global team to help ensure the safety profiles of products marketed around the world with development opportunities to ultimately provide oversight on projects and teams. Within this uniquely formed team we have two distinct roles, Medical Information and Pharmacovigilance AE Intake Specialists.It is key that you are fluent in English, as well as Nordic Languages (Swedish, Danish, Norwegian). 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.
• Prioritize and complete the assigned trainings on time
• 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(AE)/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 standards per project requirements and compliance to all project related processes and activities
• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable
• 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
• May liaise with client in relation to details on day to day case processing activities
• 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
• Lead/ Support department Initiatives
• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences
• Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
• Good knowledge of medical terminology• Fluent in English and at least one of Nordic Languages (Swedish /Danish / Norwegian)
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy, able to 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
• Self-motivated and flexible
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.