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hace 3 meses
.#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 Senior Drug Safety Officer, with at least 4 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?Check and control compliance with the deadlines and work methodology established in the pharmacovigilance agreement/contract between Azierta and clients.Perform and review the management of safety reports (PSURs, DSURs, RMPs, SMPs and ACOs).Perform quality control of the different Pharmacovigilance activities: case management, reconciliations, Authority information searches, medical information management.Preparation of reports for the client and Azierta management, e.G. preparation of monthly reports, serving as a basis for invoicing.Preparation and review of reports and signal detection analysis.Develop and review Pharmacovigilance System Master Files (PSMF).Develop and review customer pharmacovigilance standard operating procedures (SOPs/WI).Review Azierta's SOPs to verify that they are adapted to customer requirements where applicable.Develop and review pharmacovigilance agreements between Azierta and customers.Develop and review PV agreements (SDEAs) with third parties on behalf of clients.Support in Pharmacovigilance inspections and audits.Development, monitoring and evaluation of the CAPA plan applicable to projects.Conduct Pharmacovigilance audits for different clients.Review and manage Quality activities (deviations / CAPAs) related to customer Pharmacovigilance activities.Perform PV metrics and KPIs.Manage internal and external training in Pharmacovigilance.Project manager for different clients, controlling all delegated Pharmacovigilance activities (internal and external).Acting as Qualified Person Responsible for Pharmacovigilance on behalf of different clients, at European level (EU-QPPV), at local level (Local-QPPV) or acting as support.What is waiting for you?A company with a clear strategy and ambition where the people centric approach and business go hand in hand. You will be part of the ever-growing #QbDCompany3Fs: Fast pace of work, fast learning, fast growth.Full-time work.The possibility of 100% remote working, with freedom to reside in the place of Spain that you need or in any other country.If you are interested in joining a challenging project, have initiative, the ability to work in a results-oriented, fast-paced work environment, and have explosive growth prospects... this is your place
