Pharmacovigilance (EU- QPPV) Safety Data Specialist

Job Overview
IQVIA is seeking a Safety Data Specialist for Pharmacovigilance (QPPV) to develop and prepare pharmacovigilance agreements for an assigned customer. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.

Essential Functions
• Work closely with project teams to determine appropriate terms and conditions of safety agreements.
• Develop and prepare safety agreements.
• Prepare and maintain PSMFs.
• Review PSMFs prepared by other specialists. Primary customer interface on large, complex projects, responsible for developing and maintaining customer. relationships.
• Provide input to project plans to accurately reflect services provided.
• Oversee finalization and distribution of safety agreements.
• Assist in the negotiation of safety agreement text using approved processes and templates.
• Represent safety agreements team at customer meetings as required.
• Provide input into project budgets involving safety agreements.
• Provide advice, support and guidance to other staff involved in preparing safety agreements.
• Mentor and train team members.
• Perform all other duties as assigned

Qualifications
• Bachelor's Degree Preferably in health science or related area
• Experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) ideally with project management experience. or Equivalent combination of education, training or experience.
• Excellent knowledge of Lifecycle Safety processes.
• Excellent attention to detail and accuracy and maintain consistently high quality standards.
• Excellent written and verbal communication skills.
• Ability to work effectively on multiple projects simultaneously.
• Organize own workload and effectively time manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

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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.