DRUG SAFETY COORDINATOR

#WeAreAzierta, part of the #QbDGroup, a pharmaceutical consulting firm, partner of life sciences companies. We globally support our clients in the development, transformation and integral management of the life cycle of their products and services, resulting in a premium service of high quality consulting, always for the benefit of patients and consumers worldwide.We are looking for a Drug Safety Coordinator, with at least 5 years of experience in the field, especially in the production and review of safety reports, as well as in the development of Pharmacovigilance System Master Files (PSMF). Background in Pharmacy with a master in pharma industry will be positively valued.What will be your key responsibilities?To carry out activities specific to the area that include the management of assigned projects or direct interlocution with clients.Provide direct support to the area manager in decision making regarding proposal review, business area expenses and resource allocation.Identification of training needs and development opportunities for department staff.Collaboration with lower organizational levels in the improvement of existing processes.Support with the Quality Management System as it relates to their area of work and competencies.Collaborate in the planning, coordination and execution of tasks to achieve the objectives set.Participation in audits and inspections related to their area of work..Be the point of contact for the Global QA for specific issues in FV area.Centralize and control quality documentation associated with FV areaSupervise that deadline for the delivery of quality documents are met and support the technicians in charge of preparing them.Check and control the compliance of the timeframes and the work methodology established in the Pharmacovigilance agreement /contract between Azierta and the clients.Perform and review the management of the safety reports (PSURs, DSURs, RMPs, SMPs and ACOs).Carry out a quality control of the different Pharmacovigilance activities: case management, bibliographic searches, reconciliations, searches of information from the Authorities, management of medical information.Support in Pharmacovigilance inspections and audits.Perform Pharmacovigilance audits for different clients.Review and manage the Quality activities (deviations / CAPAs) related to the Pharmacovigilance activities of the clients.Perform PV metrics and KPlsWhat do we expect from you?Experience in project management and leading teamsKnowledge in European Good Pharmacovigilance Practices (GVPs).At least 5 years of proved experience in Pharmacovigilance or a written promotion by a superior.Knowledge in European Good Pharmacovigilance Practices (GVPs).Experience in preparing and managing Pharmacovigilance System Master Files (PSMFs), pharmacovigilance agreements (SDEAs) and Standard Operating Procedures (SOPs).Quality knowledge regarding the management of deviations / CAPAs.Knowledge regarding Eudravigilance requirements for Marketing Authorization Holders (clients) and the processes with the Health Competent Authorities.Experience in Pharmacovigilance audits, quality and risk management systemExcellent level of EnglishWhat is waiting for you?QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together Our promise to you: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done! Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family.#QbDGroup #JoinUs #PharmaIndustry #Pharmacovigilance #DrugSafety