descripción del trabajo

Exeltis is an organization committed to innovation, excellence and healthcare. Our aim is to become a point of reference in the pharmaceutical sector. A step forward in improving health Exeltis is the result of the natural evolution and sustained growth of Insud Pharma, an integrated health sciences group. It combines the Group’s know-how and experience with the innovative spirit of Exeltis, becoming a global organization with the capacity to discover, develop, produce and market medicinal products and medical devices that can help to improve the quality of life of millions of people worldwide. Human wellbeing and health: our driving force People are our core concern and guiding force. In order to provide better therapeutic solutions and reach more people worldwide, Exeltis has taken its operations to every continent, giving even more patients rapid and effective access to our wide range of products. Entrepreneurial organization in constant evolution With our innovative spirit, we use all our know-how, resources and human capital to develop solutions that meet patients’ unsatisfied needs. Our endeavour to find new therapeutic alternatives had led us to join forces with other leading pharmaceutical companies that share our enthusiasm and to establish alliances in order to progress together in healthcare.Position Overview:Collaborate in the creation and maintenance of an international PV system focused on the optimization of resources and infrastructures, ensuring legal and regulatory compliance.Key Responsibilities:Establish and nurture relationships with local PV departments of the Exeltis Organization, to ensure compliance with applicable regulations and company procedures.Collaborate in the maintenance of the Quality PV system of Exeltis Organization, giving support in the elaboration, update and implementation of Global Standard Operating Procedures (SOPs).Collaborate in the continuous monitoring of the risk-benefit balance of products owned by Exeltis.Ensure proper management and reporting of ICSRs to Eudravigilance, other Competent Health Authorities and partners.Participate in internal audits to affiliates and third-parties.Collaborate during inspections to Exeltis PV system.Ensure proper elaboration, review and submission of aggregate safety reports, such as PSURs, DSURs, RMPs.Collaborate in Medical Literature Process and in the review of web-pages and media relevant for PV activities.Ensure adequate interface and communication with other departments performing activities impacting Exeltis PV system, such as Regulatory Affairs, Medical, Legal, Marketing, Commercial departments at the local, regional and global levels.Keep PV files safe, accurate, updated and complete, in compliance with internal standards and applicable regulations.Required Qualifications:Education: Life Science or Health related academic degreeLanguages: Fluent Spanish and English.Experience (years/area): + 3 years of experience in a Pharmacovigilance department, preferably in a medium-large pharmaceutical company, at the Headquarter and affiliate level. Experience in Good Pharmacovigilance Practices and quality systems for PV. International environment experience.Specific Knowledge: Knowledge of the current European (GVPs) and UK PV Legislation. Knowledge and management of electronic PV databases, Clinical area in the context of Clinical Trials.Travels: Willingness to travel.Personal skills: Entrepreneurial, analytical skills, adaptability/flexibility, initiative, sociable, responsible.