Quality Assurance R&D Pharmacovigilance Specialist

Overview With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, 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. 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. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. Job Purpose The primary objective of this function is to assure the development, implementation, and maintenance of Recordati's Quality Management System in relation to Pharmacovigilance, in alignment with Group and R&D quality standards. The role involves interaction with pharmacovigilance personnel at Headquarters, the PV contact person at each SPC Affiliate, and RRD PV personnel as required. The resource will coordinate the activities of Affiliates’ QA R&D for Pharmacovigilance and liaise with local QA teams. Additionally, the resource will manage the activities of its reporting personnel at RRD Sarl - Group QA R&D – PV RRD. The resource will report directly to the Group R&D – R&D QA Manager. Responsibilities Management of Quality Assurance activities to assure the compliance with Good Pharmacovigilance Practice and Pharmacovigilance applicable regulation Management of SOPs/WIs on PV processes Pharmacovigilance Audits management QA Revision/approval of Deviations, CAPA, Change on PV topics Contribute of Training on GVP/Quality topics Contribute to Pharmacovigilance System Master File updates and review Contribute to Quality Management system periodic review Collaborate to budget preparation and revision for PV activities and invoice verification Quality oversight and support of the Pharmacovigilance teams with regard GVP Coordinate the activities of Local PV QA Active interaction and support within Group R&D QA Preparation of Group R&D SOPs/WIs on QA PV processes Revision of SOPs/WIs issued Recordati Departments/Affiliates Collaborate with QA R&D Document Management and Affiliates QA for the revision and update of SOPs/WIs Matrix HQ PV system, Affiliates, Service Providers, Business Partners Audit management Manage/oversight /coordinate Affiliates’ PV audits HQ and Affiliates Risk assessment management for audit prioritization (Affiliate, Partners, Service Providers, PV System) Strategic and Annual PV Audit Programme management Ensure HQ and Affiliates inspection readiness Revision /approval of HQ and Affiliates Audit Plan/Report, Deviations, Audit/Inspection CAPA, Change controls on PV topics Required Education Life science or other relevant qualifications Required Skills And Experience 6-8 years experience in the same role in Pharmaceutical companies and/or PV CROs Project Management Microsoft Word, Excel, PowerPoint, Teams and Outlook Software knowledge (e.g. eDMS) Computer System Validation knowledge Knowledge of QA Standards Ability to propose solutions, take decisions and/or refer to manager Ability to work across cultures Flexible and adaptable Initiatives and self-motivation capacities Positive thinking and enthusiasm Ability to travel on a periodic basis Strict on confidentiality, rules, procedures and timelines Positive attitude and ability to interact and communicate diplomatically and professionally with internal and external customers in a global environment Excellent organization skills and ability to handle multiple competing priorities within tight timelines Management / Leadership skills Required Languages Fluent in English (spoken and written). 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. 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. 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. #J-18808-Ljbffr