Signaling and Risk Management Specialist

Cria Technologies; Campania; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A 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 field, 1-3 years of experience, and fluency in English. This position offers a chance to work in a dynamic environment on critical safety processes.

Competenze

• 1-3 years of working experience in similar roles.
• Fluent English (both written and spoken).
• Up-to-date knowledge of international reporting and regulatory regulations.

Mansioni

• Provide analytical inputs into the risk/benefit profile assessment of global products.
• Identify and evaluate new signal detection methodologies and tools.
• Conduct systematic reviews of aggregate safety data.

Conoscenze

Analytical skills

Knowledge of Pharmacovigilance

Strategic thinking

Problem solving

Planning and organizational skills

Proficiency with IT systems

Team player

Formazione

Master’s degree in science, medicine, biology or related fields

PhD preferred

Strumenti

EudraVigilance

Descrizione del lavoro

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.

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 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).