Drug Safety Physician

hace 4 semanas


Madrid, España Importante Empresa A tiempo completo

Overview:Responsibilities:Perform medical assessments of adverse event reports and MedDRA adverse event coding.Prepare and/or review aggregated reports, such as Periodic Safety Update Reports, Development Safety Update Reports, Addendums to Clinical Overviews, Risk Management Plans, among others.Provide input to benefit risk-assessments and Clinical Expert Statement as applicable.Review documents related to clinical trials and post-authorization safety studies where the R&D departments and companies of Insud Pharma require support.Give medical support to the manufacturing sites when reassessment of the benefit-risk balance of manufactured products is required.Provide answers to medical inquiries and prepare benefit risk assessments reports if needed.Provision of a medical expert opinion in medical monitoring, signal detection, and risk management activities.Participate in the decision-making performed by the Signal Management Team and Signal Detection Committee.Provide 24/7 medical assistance to the Qualified Person of Pharmacovigilance (QPPV).Collaborate in the establishment of a Quality Pharmacovigilance System for the Medical Safety and Business Support Department within Insud Pharma Global Pharmacovigilance Department.Provide medical safety evaluations for the creation and maintenance of product information documents (e.G. Reference Safety Information/Core datasheets/SmPC).Collaborate with other departments and business units of Insud Pharma, affiliates, and business partners.Collaborate with external key stakeholders as applicable.Qualifications:Education: Degree in Medicine. A full and partly completed postgraduate program with a curriculum in pharmacovigilance would be advantageous.Experience (years/area): Hospital medical experience in patient care (e.G. medical residency of internal medicine, clinical pharmacology, or similar) and preferentially some years of experience in a PV Department of a medium-large pharmaceutical company, a CRO, or in a hospital setting managing the system of adverse event reporting.Specific Knowledge: Knowledge of pharmacovigilance vocabulary and current European PV Legislation and Good Pharmacovigilance Practices (GVP).Languages: Fluent in Spanish and English. Knowledge of other languages will be an asset.Travels: Willing to travel, as required.Personal Skills: Communication, analytical skills, sense of responsibility, sociable, flexibility.#J-18808-Ljbffr


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