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Signaling And Risk Management Specialist

4 ore fa

Rome, Italia IQVIA Italia A tempo pieno

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 Ph D 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., Eudra Vigilance).
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).