Signaling 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 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.

• 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).

1-3 years of working experience in similar roles.

Master’s degree in science, medicine, biology, or related fields. A PhD or similar preferred.

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., Eudra Vigilance).
• Good working knowledge of common office software.
• Team player.

Chemical Contract permanent.