Global PV Operations Lead Recordati Rare Diseases

<p>With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. <br/> <br/> We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. <br/> <br/> At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. <br/> <br/> This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. <br/> <br/> Recordati. Unlocking the full potential of life<br/></p> <p><strong>Role Overview</strong></p> <p>Reporting into the Head of Global PV Rare Diseases, the Global PV Operations Lead will conduct and oversee PV operations for Recordati Rare Diseases (RRD) PV Group,. Role is responsible for</p> <ul><li>Management and delivery of the pharmacovigilance function</li><li>Oversight &amp; Management of all outsourced activities to the vendor dealing with PV operations</li><li>Data management (triage, case processing, coding conventions, distribution, submission, reconciliation and literature screening</li><li>Database contact point (Coordination/ liaison) and supervise LL extraction.</li><li>Vendor Management set up, oversight &amp; performance KPI covering PV activities case processing, submission, distribution, reconciliations, literature screening</li><li>To prepare and maintain all documentation and SOPs as required for the management of Pharmacovigilance Operations activities within the organisation, and PV vendor</li><li>Support Global PV System with appropriate process, documentation and KPI for all PV matters relative to data management</li><li>Establish a proper periodic quality control of cases and CAPA where appropriate</li><li>Act as the key contact during inspection for all PV Operations for data management</li><li>To lead the delivery of pharmacovigilance operations across the global business through the global team and in collaboration with functions (others groups in RRD PV, in Patient safety groups, R&amp;D, Clinical Regulatory, QA, Legal) with support of a team member</li><li>To ensure sufficient knowledge on the Global safety database to ease communication with Patient Safety group, appreciate impact of changes on RRD products, line listing production, contribute to database improvement</li><li>Act as a key member of the management group to develop, contribute and drive delivery and focus across the business in line with the company objectives</li></ul> <p><strong>Key Skills and Experience</strong></p> <ul><li>At least 3 years experience in PV CRO Vendor management and case processing management</li><li>Strong Regulations knowledge and experience of - EU / US / Canada …. within a Compliant environment</li><li>Management experience and leadership skills</li><li>Attention to detail and accuracy of data</li><li>Must be resilient with a pragmatic approach within a changing environment</li></ul> <p>At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.</p> <p>We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.</p> <p>If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.<br/></p>