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IQVIA
,
Reading, Berkshire
Senior Marketed Product Safety Specialist - Based Anywhere in UK Or Europe
Overview
Job Description
IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. This role can be based anywhere in UK or Europe PURPOSE Develop and prepare pharmacovigilance agreements for assigned customers. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV. RESPONSIBILITIES * 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 * May assume the responsibilities of EU QPPV or deputy QPPV as outlined in Quintiles Work Instruction: CS_WI_LS0013 Lifecycle Safety-Qualified Persons fo Lifecycle Safety-Qualified Persons for Pharmacovigilance (QPPV) All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * 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 MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree or educational equivalent in health science or other directly related field and a minimum of 3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience or equivalent combination of education, training or experience. PHYSICAL REQUIREMENTS * Extensive use of keyboard requiring repetitive motion of fingers. * Extensive use of telephone and face-to-face communication requiring accurate perception of speech * Regular sitting for extended periods of time. * May require occasional travel. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.