Pharmacovigilance Quality Manager

Job Description

QA Manager - PharmacovigilanceLeicesterPermanent £65,000-£70,000Kelly Scientific have partnered with an Innovative Pharmaceutical business to recruit a Pharmacovigilance Quality Assurance Manager to join the Quality Assurance team, reporting to the Head of QA. The purpose of this role is to provide quality assurance oversightof our Pharmacovigilance system and oversight of drug promotion activities to ensure these are ethical. The successful candidate will work closely with the QA team, Sales Representatives and distributors to ensure compliance with EU Pharmacovigilance Directives and the ABPI Code of Practice. In addition this role will act as a Subject Matter Expert (SME) in these areas. Based in the companys manufacturing unit, the role will involve: * Represent QA as an initial or assigned point of contact in relation to Pharmacovigilance (PV) and ethical drug promotion. * Conduct assigned PV routine, and if required, for cause audits of distributors and vendors * Ensure rapid communication of PV QA issues including critical audit findings, potential misconduct or issues of significant deviation within PV systems/ processes/ project to appropriate leaders and colleagues * Serve as member of assigned project teams with participation in the applicable forums, providing PV compliance advice and guidance to PV contractor to achieve continuous quality improvement and effective quality controls * Interface with relevant stakeholders, as appropriate to provide Good Pharmacovigilance and QA guidance and input on promotional materials and risk management materials. * In partnership with PV contractor, contribute to the development of PV risk assessments, Pharmacovigilance System Master File, Product Safety Update Reports and Safety Data Exchange Agreements * Provide support in assessment of potential root causes and remediation (corrective and preventative actions) * Participate in the development/enhancement of Pharmacovigilance procedures, guidance documents and safety data exchange agreements. * Develop and deliver training sessions on PV topics internally and externally for employees and external partners. * Act as a strong technical resource and is called upon to resolve PV issues based on knowledge of relevant PV regulations, guidelines and local regulations * Serve as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge * Assist with the preparation or review of relevant SOPs or policies relevant to Pharmacovigilance. * Interface with internal QA functions to ensure appropriate quality oversight of third parties including oversight of sales and marketing materials strategy. The ideal candidate will have the following experience and abilities: * At least 5 years QA Experience, within the Pharmaceutical or Biotechnology industry. * Extensive knowledge of Pharmacovigilance Regulations including Directive 2010/84/EU, Regulation EU 1235/2010, EU 5201/2012, EU 1027/2012 and directive 2012/26/EU * Working knowledge of the ABPI Code of Practice, IFPMA, EFPIA and the MHRA Blue guide. The ideal candidate will also have a working knowledge of: * The Rules Governing Medicinal Products in the European Union (EudraLex) - Volume 4 (confirms to EU directive 2003/94/EC) * Related key directives including 2001/83/EC (Medicinal Products for Human Use), 2001/20/EC the Clinical Trials Directive, The Clinical Trials Regulation 536/2014 * US Code of Federal Regulations 21 CFR parts 210, 211, 820 and 312. * ISO 13485:2016. This is a fantastic opportunity to join an innovative business with experts across the business with a great culture and benefits package, If you feel you have the right background, please apply or contact the Kelly Scientific Team for more information.Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kellys Privacy Statement. For information regarding data protection at Kelly, please visit theKelly website and have a look into the Privacy Statement.As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.