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 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 streamlining 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 aggregates 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)
Tecnichal skills:
* 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.
Soft skills:
* Team player
* Effective problem solver
* Strong time management skills
* Excellent communicator
TYPE OF CONTRACT:
Chemical Contract permanent
IQVIA 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).