Signaling and Risk Management Specialist
1 giorno fa
Signaling and Risk Management SpecialistOn behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry, a global pharmaceutical company - IQVIA is looking for a Signaling and Risk Management Specialist who can join an exciting working environment in a dynamic atmosphere.The person acts as a process owner of safety monitoring, contributing to the lifecycle management activities of global products to ensure patient safety and compliance with global regulatory and quality standards.Main responsibilities:Provide analytical inputs into the risk/benefit profile assessment of global products, by analyzing pre- and post-marketing data.Identify and evaluate new signal detection methodologies, tools, and data sources to improve patient’s safety and streamline processes.Identify and assess new safety signals/issues and trends by conducting systematic reviews of aggregate safety data, e.g. spontaneous and non-interventional adverse event reports.Monitor health authorities’ websites for signal detection purposes and to share results with relevant internal and external stakeholders.Be responsible for ad hoc risks analyses of global products.Provide input in managing safety sections of aggregate reports (PSUR, DSUR, RMP, ACO, PI).Provide guidance and support to local affiliates in signal management processes.Plan and manage signal management meetings and related minutes and actions.Represent Signal Management in audit and inspections.Maintain Standard Operating Procedures and Working Instructions concerning signal management and related processes in collaboration with relevant departments.Develop training materials and provide training on signal management and product quality complaints to global colleagues and local affiliates.Be accountable for the Product Quality Complaints process.Contribute to the evaluation and oversight of the Product Quality Complaints process.Contribute to medical enquiries evaluation for signal detection purposes and supervise third parties in the management of the process.Support Safety Physicians in aligning risk management materials with the current approved documents (incl. PBRER, ACO, PADER, RMP, presentations, signal evaluations)Required experience: 1-3 years of working experience in similar roles.Education: Master’s degree in science, medicine, biology, or related fields. A PhD or similar preferred.Languages: Fluent English (both written and spoken).In-depth knowledge of Pharmacovigilance at both global and local levels.Strong analytical skills, with expertise in signal detection and analysis.Strategic thinking, problem solving and decision making abilities.Excellent planning and organizational skills, with attention to details and a result-oriented approach.Ability to organize and prioritize tasks individually and across teams to achieve established deadlines while maintaining high-quality performance.Up-to-date knowledge of international reporting and regulatory regulations to ensure compliance.Proficiency with key IT systems and databases relevant to pharmacovigilance (e.g., EudraVigilance).Good working knowledge of common office software.Team player.TYPE OF CONTRACT: Chemical Contract permanentIQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into
-
Signaling and Risk Management Specialist
1 giorno fa
Naples, Italia Cria Technologies A tempo pienoSignaling and Risk Management Specialist On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry, a global pharmaceutical company - IQVIA is looking for a Signaling and Risk Management Specialist who can join an exciting...
-
Global Signal
1 giorno fa
Naples, Italia Cria Technologies A tempo pienoA leading pharmaceutical company in Italy is seeking a Signaling and Risk Management Specialist to monitor patient safety and ensure compliance with regulatory standards. The role involves analyzing risk/benefit profiles, conducting safety assessments, and providing support to local affiliates. The ideal candidate will have a Master’s degree in a related...
-
Insurance Risk Engineer
4 settimane fa
Naples, Italia MAG A tempo pienoMAG Consulting, società del Gruppo MAG, sta cercando una risorsa che sarà inserita nel dipartimento tecnico e avrà il compito di supportare la gestione dei rischi , la sottoscrizione assicurativa e la consulenza ai clienti corporate . La ricerca è volta per le sedi di Napoli o Milano. Chi Siamo MAG Spa è un'Azienda Leader nel settore assicurativo , dal...
-
Insurance Risk Engineer
3 settimane fa
Naples, Italia MAG A tempo pienoMAG Consulting, società del Gruppo MAG, sta cercando una risorsa che sarà inserita nel dipartimento tecnico e avrà il compito di supportare la gestione dei rischi , la sottoscrizione assicurativa e la consulenza ai clienti corporate . La ricerca è volta per le sedi di Napoli o Milano. Chi Siamo MAG Spa è un'Azienda Leader nel settore assicurativo , dal...
-
Assistant Pool and Beach Manager
2 settimane fa
Naples, Italia Four Seasons Hotels and Resorts A tempo pienoAbout Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to be treated in return. Our team members around the world create amazing experiences for our guests, residents, and partners through a commitment to luxury with genuine...
-
Naples, Italia Four Seasons Hotels and Resorts A tempo pienoA luxury hotel chain in Campania seeks a Learning & Development Specialist to foster a rich learning culture for employees. This full-time role involves designing and executing a training strategy, organizing learning offerings, and facilitating programs like orientation. The ideal candidate demonstrates professionalism and strong communication skills....
-
Quality Assurance Specialist
2 settimane fa
Naples, Italia Manpower A tempo pienoLa Divisione Beyond di ManpowerGroup, per importante realtà Cliente del mondo chimico farmaceutico, ricerca un/una Quality Assurance Specialist appartenente alle Categorie Protette (L.68/99) Principali Mansioni: - Supportare le attività relative alla qualità e alla conformità in ambito GMP/GDP; - Supportare le attività relative alle linee guida sui...
-
Quality Assurance Specialist
2 settimane fa
Naples, Italia Manpower A tempo pienoLa Divisione Beyond di ManpowerGroup, per importante realtà Cliente del mondo chimico farmaceutico, ricerca un/una Quality Assurance Specialist appartenente alle Categorie Protette (L.68/99) Principali Mansioni: - Supportare le attività relative alla qualità e alla conformità in ambito GMP/GDP; - Supportare le attività relative alle linee guida sui...
-
Naples, Italia Nicklaus Children’s Health System A tempo pienoA children's health organization is seeking a dedicated Neonatal Nurse Practitioner to provide comprehensive care for high-risk newborns and infants. This role involves diagnosing medical issues, developing care plans, and maintaining active certifications. Candidates must hold a Master's degree or DNP, a Florida APRN Licensure, and have at least two years...
-
Talent Acquisition Specialist
2 settimane fa
Naples, Italia Four Seasons Hotels and Resorts A tempo pienoAbout Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to be treated in return. Our team members around the world create amazing experiences for our guests, residents, and partners through a commitment to luxury with genuine...
