Corporate PV Governance Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7817lq

ppFounded in 1946, Fidia is an Italian multinational pharmaceutical company, with RD, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Eye Care, Skin Care, Specialty Care, HealthWellness Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries. /p h3Job Description /h3 pWe are recruiting a /p h3Corporate Pharmacovigilance Governance Expert - Temporary contract /h3 pThe candidate will support the management and oversight of the Corporate PV Governance Unit activities. /p h3Main responsibilities: /h3 ul liSupport the management of the Affiliates and their oversight related to the Pharmacovigilance System, ensuring that contract and Pharmacovigilance Agreement (PVA) related to medicinal products are in place with Affiliates, and verify compliance monitoring; /li liSupport the management, release and reporting of the Pharmacovigilance System Master Files (PSMFs) for human and veterinary products, and any Pharmacovigilance Sub-System Master File (PSSF); /li liSupport the preparation of materials and delivery of training on pharmacovigilance at HQ and Affiliates level; /li liSupport the management of GVP Audit and Inspection and ensure Deviation CAPA management; /li liContribute to Key Performance Indicator (KPI) Management at Corporate Level for the Pharmacovigilance System of human and veterinary products; /li liContribute to write and review the Corporate SOPs/Wis and Quality Management Review (QMR)



for the Pharmacovigilance System; /li liContribute to ensure that sponsored digital assets comply with pharmacovigilance requirements; /li liContribute to the management of GVP archives for the pharmacovigilance system; /li liContribute to Regulatory Intelligence for EU Territories for the Pharmacovigilance System. /li /ul h3Requirements: /h3 ul liDegree in Pharmacy, Pharmaceutical Chemistry, Biology, Biotechnologies or other scientific related fields. A second level master's degree in Pharmacovigilance is considered a plus; /li liAt least 1 year of experience in a similar role within Pharmacovigilance; /li liA good knowledge of EU GVP is required, and familiarity with international pharmacovigilance regulations would be an advantage; /li liPrevious involvement with the management of the PSMF is preferred; /li liProficiency in the use of Microsoft Office Suite (i.e. Excel, Word, Outlook and Teams); /li liFluency in written and spoken English; /li liPlanning, organizational and analytical skills are required, as well as problem-solving and teamwork skills. /li /ul h3Our offer: /h3 ul liOne-year fixed term contract; /li liSalary between € 30.700 and € 38.300; /li liCollective Premio and company Welfare. /li /ul h3Fidia benefits: /h3 pIn Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign. /p pFidia Farmaceutici promotes parity and inclusion in all its actions. /p pAll people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age. /p pAll company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People Culture Department. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7817lq