PpDescrizione dell’offerta di lavoro /ppOn 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. /ph3Overview /h3pThe 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. /ph3Responsibilities /h3ulliProvide analytical inputs into the risk/benefit profile assessment of global products, by analyzing pre- and post-marketing data. /liliIdentify and evaluate new signal detection methodologies, tools, and data sources to improve patient’s safety and streamline processes. /liliIdentify 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. /liliMonitor health authorities' websites for signal detection purposes and to share results with relevant internal and external stakeholders. /liliBe responsible for ad hoc risks analyses of global products. /liliProvide input in managing safety sections of aggregates reports (PSUR, DSUR, RMP, ACO, PI). /liliProvide guidance and support to local affiliates in signal management processes. /liliPlan and manage signal management meetings and related minutes and actions. /liliRepresent Signal Management in audit and inspections. /liliMaintain Standard Operating Procedures and Working Instructions concerning signal management and related processes in collaboration with relevant departments. /liliDevelop training materials and provide training on signal management and product quality complaints to global colleagues and local affiliates. /liliBe accountable for the Product Quality Complaints process. /liliContribute to the evaluation and oversight of the Product Quality Complaints process. /liliContribute to medical enquiries evaluation for signal detection purposes and supervise third parties in the management of the process. /liliSupport Safety Physicians in aligning risk management materials with the current approved documents (incl. PBRER, ACO, PADER, RMP, presentations, signal evaluations). /li /ulh3Requirements /h3ulliRequired experience: 1-3 years of working experience in similar roles /liliEducation: Master’s degree in science, medicine, biology, or related fields. A PhD or similar preferred. /liliLanguages: Fluent English (both written and spoken) /li /ulh3Skills /h3ulliIn-depth knowledge of Pharmacovigilance at both global and local levels. /liliStrong analytical skills, with expertise in signal detection and analysis. /liliStrategic thinking, problem solving and decision making abilities. /liliExcellent planning and organizational skills, with attention to details and a result-oriented approach. /liliAbility to organize and prioritize tasks individually and across teams to achieve established deadlines while maintaining high-quality performance. /liliUp-to-date knowledge of international reporting and regulatory regulations to ensure compliance. /liliProficiency with key IT systems and databases relevant to pharmacovigilance (e.g., EudraVigilance). /liliGood working knowledge of common office software. /li /ulh3Soft skills /h3ulliTeam player /liliEffective problem solver /liliStrong time management skills /liliExcellent communicator /li /ulh3Type of contract /h3pChemical Contract permanent /ph3Note /h3pIQVIA 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 account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA's Clients. The research is urgent and is intended for candidates of both sexes (L.903/77). /p /p #J-18808-Ljbffr