Pharmacovigilance Database Specialist

Job Description

Are you an experienced PVG Database Principal looking for an exciting new job opportunityWe are currently looking for a PVG Database Principal to join a leading pharmaceutical company based in the West Yorkshire area. As the PVG Database Principal you will be responsible for providing technical expertise on pharmacovigilance systems, specifically the companys safety database (Veeva Vault) and allied systems and serve as the subject matter expert for these systems.KEY DUTIES AND RESPONSIBILITIES:Your duties as the PVG Database Principal will be varied however the key duties and responsibilities are as follows:1. You will be responsible for proactively identifying database requirements to maximize efficiency and quality of end user performance; takes initiative to investigate, develop and implement solutions as well as presenting these solutions to management.2. You will also be responsible for managing the configuration/validation of the pharmacovigilance database, leading the safety database and associated systems upgrades/patches for the PV team in liaison with the database vendor as well as lead project kick-offfor migration activities including validation and configuration (data imports and exports). 3. Additionally, as the PVG Database Principal, you will also lead development, validation, and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.4. You will help develop staff knowledge of the safety database through individual mentoring, classroom trainings and/or user workshops as needed.ROLE REQUIREMENTS:To be successful in your application to this exciting opportunity as the PVG Database Principal we are looking to identify the following on your profile and past history:1. Relevant Life Science degree and experience working in a pharmacovigilance department (case processing and regulatory authority reporting) is essential for this position.2. Additionally, in depth experience of using at least one industry recognised safety database, hands on knowledge of E2B R2 and R3 in relation to the databases is also required for the role of PVG Database Principal.3. Working knowledge of Good Vigilance Practice as described in the EMA modules as applicable to Europe and UK as a minimum. Experience of creating reports and queries of the safety database in suitable format for use in Risk Management Plans, Product SafetyReports and Periodic Safety Update Reports (PSURs).Key Words: Pharmacovigilance Database Principal | PVG | Safety Database | Pharmaceutical | Regulatory Affairs | Life Science | MHRA Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS isa company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.