Product Vigilance Manager, Argus Product Dictionary Single Point of Contact and Report Specialist

Procter & Gamble ,
Reading, Berkshire
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Description The role is part of the Global Safety Surveillance & Analysis (GSSA) Organization in Procter & Gamble. GSSA is focused on delivering product safety and regulatory compliance. We partner with the Human Safety Organisation to provide continuous safety support throughout the life cycle of our products. Specifically, GSSA delivers post-market safety support by establishing and maintaining global systems and work practices necessary to ensure global regulatory compliance with current surveillance and pharmacovigilance related regulations. This work includes monitoring post-market safety through individual and aggregate analysis of adverse event (AE) data and signal detection and management practices. As a Product Vigilance Manager (PVM), you will be responsible for managing, monitoring and understanding in-market product safety for P&G products sold worldwide to: i) ensure consumer safety and regulatory compliance ii) enhance existing systems and improve current work processes for safety surveillance iii) analyse health related consumer complaints for signal detection and continual product improvement. You will be the expert within GSSA with respect to the in-market safety profile, symptom profile and special issues for your assigned product categories. You will obtain a good understanding of relevant regulations and ensuring that all regulatory submissions are processed in accordance with applicable regulations and requirements. You will be the product vigilance single point of contact for other P&G functions. You will be responsible for signal detection and signal management activities associated with your assigned product categories. As an Argus Product Dictionary Single Point of Contact (SPOC), you will be responsible for the maintenance of our Argus safety database product dictionary to fulfill business requirements. Argus is the database used by GSSA to manage all the AEs reported to P&G in relation to our products. The completeness and accuracy of the product dictionary within Argus is essential to allow GSSA to associate these AEs to the correct product. As a Report Specialist, you will be responsible for supporting Product Vigilance Managers (PVMs) to deliver aggregate AE reports (e.g. Periodic Safety Update Reports) for medical devices globally. Good to Know: We are an equal opportunity employer and value diversity at our company. Our people are all equally talented in unique ways: we come from diverse traditions, personal experiences and points of view. And we want to include yours. Are you ready to inspire us with your unrivalled ideas? P&G ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process. Please contact us to request an accommodation by clicking 'application help' at the top right-hand corner of the career website. Posting date : 11th June 2020 Application Deadline : You must have completed the online application and the subsequent online tests by 9th July 2020 in order to be considered for this role. Any applications or tests taken after this date will not be considered. Qualifications Requirements(skills/ experiences) for the role: * The candidate must have a life sciences background with a minimum of an MSc (or BSc and subsequent post-graduate qualification) in a life sciences subject, specifically a subject that focuses on human biology/health (e.g. medicine, pharmacology, physiology). * The candidate must have experience working in the consumer goods industry. They must also have experience working with regulated products such as medicines, medical devices and cosmetics and have knowledge of the regulations that apply to them. * The candidate must have experience with Safety Surveillance and Regulatory Affairs from a consumer products environment. * They must have experience in the handling and reporting of adverse events. They must also have experience with aggregate reports such as Periodic Safety Update Reports (PSURs) for products such as medical devices or medicines. The candidate must have experience with databases used to capture and handle consumer data relating to human health. * The candidate must have experience working with external Regulatory Authorities, specifically in the areas of communication and influencing. * The candidate must have a high attention to detail. They must be thorough and detail-oriented with a real drive to be complete and accurate in their work. The work to be done by the candidate is critical to ensure ongoing compliance with regulatory requirements and so the candidate must have a proven ability to deliver compliant work on time. * The candidate must have a proven ability to communicate effectively, both orally and in writing, with an emphasis on communication of scientific information. They must be able to communicate effectively with a diverse range of functions from technical personnel through to senior management. * The candidate must have a proven abil

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