Document Manager and Audit Co-ordinator, Global Safety Surveillance & Analysis

Procter & Gamble ,
Egham, Surrey
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Description The Global Safety Surveillance & Analysis (GSSA) Organization has a mission to be the stewards of consumer safety and global compliance, working continuously to improve our products for the world's consumers. Specifically, delivering 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. The Role: We are looking for someone to take the role of Document Manager and GSSA Audit Co-ordinator within the GSSA Organisation. As a Document Manager, you will provide support in the development, tracking, version control, and archiving of work process and reference documents and reports using a standard global document hierarchy and template. Specifically you will: * Develop and maintain an accurate and complete standardized documentation system for GSSA pharmacovigilance processes and procedures. * Develop, catalogue and store all GSSA documentation on the GSSA Sharepoint site. * Help to manage GSSA training content on the My Learning site. * Support the execution of the P&G Corporate document retention policy against GSSA documents/records * Ensure archiving of GSSA files related to management of historical safety data issues arising globally (company responses, source data etc). As a GSSA Audit Co-ordinator, you will provide support to the management and co-ordination of all GSSA audits, inspection and assessments. Specifically you will support the GSSA Principal Scientist and Regulatory Compliance Lead to: * Establish and maintain global inspection readiness practices, including a comprehensive Self Improvement Program (SIP) audit schedule globally * Co-ordinate preparation for GSSA audits, inspections and assessments including managing pre-work and ensuring appropriate resources are in place and act as a resource whilst they are taking place * Co-ordinate development of corrective and preventative actions to address all GSSA outages discovered What we offer you: * Continuous coaching - you will work with passionate people and receive both formal training as well as day-to-day mentoring from your manager * Dynamic and respectful work environment - employees are at the core, we value every individual and encourage initiatives, promoting agility and work/life balance * We offer a competitive compensation and benefits package. This includes pension, life assurance, health insurance, flexible working, a stock ownership scheme and other social benefits. Regular salary revisions and possible promotions - all in line with your results, performance and potential. To find more information about our benefits package take a look here: Qualifications Requirements for the role: Technical Mastery. This position requires a motivated Associate Scientist, ideally with a life sciences background. Experience with Safety Surveillance, Global Product Stewardship or another compliance-related function would be a great addition High attention to detail. The candidate must be thorough and detail-oriented with a real drive to be complete and accurate in their work. Experience with external communications (regulatory authorities, industry groups) would be of use but is not essential. An aptitude for systems in general and experience with electronic data capture systems is desirable. Builds Diverse and Collaborative Relationships. GSSA partners with multiple functions within P&G globally, often virtually. The successful candidate must therefore have the ability to build and nurture further collaborations Operates with Discipline/Agility. GSSA is a dynamic, rapid-pace organization, thus you will need to be agile and able to focus on priorities and execute against them. Good to Know This role will initially be based in Egham but then will transition to Reading in April/May 2020 as part of the expansion of Reading site becoming our Greater London innovation Centre - you therefore must be comfortable with your eventual work location being Reading. We are an equal opportunity employer and value diversity at our company; Our people are all unique: 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. Qualifications: Requirements for the role: Technical Mastery. This position requires a motivated Associate Scientist, ideally with a life sciences background. Experience with Safety Surveillance, Global Product Stewardship or another compliance-related

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