Local Safety Partner

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Safety Partner, you will be responsible for supporting and implementing product safety strategies for a portfolio of products primarily used in autoimmune diseases. Working closely with local and global stakeholders, you will contribute to the continuous monitoring of product benefit-risk profiles, support signal management activities, and ensure compliance with pharmacovigilance requirements while helping identify unmet patient and healthcare professional needs. Main responsibilities : Develop and maintain expert knowledge of assigned products’ safety profiles and provide safety expertise to internal and external stakeholders. Monitor product safety through spontaneous reporting, case documentation, signal detection activities, off-label use monitoring, scientific literature review, competitor surveillance, and global safety communications. Assess safety information and contribute to the implementation of appropriate risk mitigation measures. Manage product safety inquiries and provide tailored responses in collaboration with relevant functions when required. Contribute to the preparation and review of safety sections for aggregate reports, therapeutic use programs, compassionate use programs, clinical studies, and other medical or regulatory documents. Support the communication of safety information, including labeling updates, DHPCs, safety memos, and other risk minimization materials. Participate in pharmacovigilance investigations and support the management of legal safety cases. Contribute to the local adaptation and implementation of risk minimization measures and assessment of their effectiveness. Perform safety reconciliations for local sponsored studies. Represent the Safety function in cross-functional meetings and provide pharmacovigilance expertise to support product strategies and launches. Identify unmet needs for patients and healthcare professionals and contribute to the development of appropriate action plans. Ensure compliance with applicable regulations, company policies, procedures, compliance standards Degree in Medicine, Pharmacy, Life Sciences, or a related scientific discipline. Solid experience in Pharmacovigilance within the pharmaceutical industry (post-marketing and/or clinical trials) Experience working within a pharmaceutical affiliate environment is highly desirable. Strong knowledge of pharmacovigilance regulations, drug safety processes, and risk management principles. Ability to analyze complex safety data and make informed decisions in a fast-paced environment. Strong strategic thinking and problem-solving skills. Excellent organizational skills with the ability to manage multiple priorities effectively. Strong interpersonal, communication, and stakeholder management skills. Ability to work effectively within a cross-functional and matrix organization. Experience supporting change management initiatives is an advantage. Professional English proficiency a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; } Why Join Us? At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here’s what makes us unique. We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.