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 We are looking for a PV Safety Assessment Specialist to monitor the products safety profile ensuring an effective and compliant management of all pharmacovigilance and vigilance activities related to Benefit-Risk assessment. Key Responsibilities Evaluation of the safety profile of medicinal products (corporate HQ and local Italian), medical devices, cosmetics and food supplements applied to pre-marketing (clinical studies) and post-marketing. Planning and generation of safety documents relevant to the Benefit-Risk assessment for medicinal products of HQ competence (e.g., PSUR, DSUR, RMP and related risk minimisation measures, signal detection reports). Planning and preparation of the safety documents relevant to the Benefit-Risk assessment for medical devices, food supplements and cosmetics (e.g., Trend Analysis, PSUR, PMS plan, cumulative safety reviews). Generation of Safety Management Plans for interventional and non-interventional studies/market research/patient support programmes for medicinal products, medical devices, food supplements and cosmetics, as applicable. Regular review of the safety data, including EVDAS, to detect new safety signals (signal detection process) and evaluation of Benefit-Risk ratio for medicinal products of HQ competence. Support to the ICSR processing group for the assessment of relevant individual cases. Support for the Clinical Overview and any other safety analysis documents preparation relevant to regulatory procedures for medicinal products of HQ competence (e.g., MAs, variations, SmPC harmonization). Support in reviewing and updating safety sections of the Technical File for medical devices and dossier of non-pharmaceutical products. Support to the preparation of Clinical Evaluation Report (CER), Post-market Clinical Follow-up (PMCF) and PMCF studies. Bilateral exchange of safety information with Affiliates and Partners in accordance with the enforced Safety Data Exchange Agreements. Collaborate with the Safety Medical Advisor for the analysis and medical review of the generated documents. Review and update of the safety section of the Summary of Product Characteristics (SmPC) and of the Core Data Sheet (CCDS) for products of HQ competence and of Investigator's Brochure (IB) for investigational products, in collaboration with R&D and Regulatory Department. Management of safety issues associated to medical inquiries, technical complaints and product recalls in agreement with the enforced legislations. Management of safety issues related to clinical studies, including documentation revision, in agreement with the enforced legislations and company SOP/WI. Training for continuous education of internal personnel and sales force on safety issues related to products of competence. Support the Affiliates for any activities related to Benefit-Risk assessment of medicinal products, medical device, cosmetics and food supplement. Support in reviewing safety relevant sections of marketing and promotional materials. Generation and updating of SOPs/WIs concerning pharmacovigilance and vigilance processes and activities. Required Education Scientific degree. Master in pharmacovigilance is a plus. Required Skills And Experience At least 3 years experience in a similar role. Good knowledge of Argus or similar PV Database. Able to work in a team and problem-solving skills. Past experience in Regulatory Affairs is a plus. Analytical skills. Required Languages Good knowledge (written and oral) of the English language is required. Further knowledge of languages is a plus. 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