Pharmacovigilance/ Medical Information Specialists - Dutch/English Bilingual
- Experience Level
- Entry level
Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.
• 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
• Determine initial/update status of incoming events, code AE and Products, write narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
• Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
• Liaise with manager for regulatory tracking requirements and electronic reporting.
• Ensure to meet quality, productivity and delivery standards per project requirements.
• Build a positive, collaborative team environment with Safety team members.
• Bachelor's Degree in Scientific, Healthcare or Life Science discipline
• Excellent written and verbal skills in English and Dutch
• Excellent organizational skills, time management skills, attention to detail and accuracy.
• Excellent working knowledge of Microsoft Office and web-based applications
• Excellent verbal/written communication skills
• Proven ability to work independently and autonomously with policies and practices
• Proven ability to multi-task, meet strict deadlines, manage competing priorities
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.