Gruppchef Saftey/Vigilance till Q-Med

Job Summary Oversees the Device and Drug Safety operation of Q-Med AB and its global market.The successful candidate will provide leadership and management to the Safety/Vigilance group at Q-Med AB.Reporting to the Chief Medical Officer and Head of Medical Affairs, the successful candidate is responsible for the quality, compliance and strategic development of device and drug safety operations at Q-Med AB in Uppsala.Responsibilities This position involves personnel and budget responsibilities for the Safety/Vigilance group.This position of group manager is accountable for regulatory compliance of all device and drug safety operations performed by the group through .maintenance of device and drug safety database and procedures to enable collection, data entry, medical assessment, reporting, monitoring and trending of adverse event case reports and medical complaints .continuous evaluation of safety for products under clinical development and post- market approval .provide innovation and strategy to develop, implement and enhance vigilance and pharmacovigilance plans including comprehensive risk benefit assessments and risk minimization/management plans to establish and appropriately communicate safety profile of products .convey safety information/messages to internal customers including senior management, subsidiaries, marketing and sales teams and externally to regulatory agencies and government authorities worldwide, key customers, stakeholders and patient community as required. Experience and Qualifications .Qualification in medicine, pharmacy or a relevant scientific discipline..At least 5 years of management experience in a relevant field, preferably in international vigilance/pharmacovigilance operations..High level experience in device/drug safety including in-depth knowledge and working compliance experience with worldwide safety regulations..Understanding of medical and scientific principles associated with administration of products..High level of technical and ethical expertise..Experience in writing complex safety/clinical analyses..Fluency in both English and Swedish.You can find more information and apply at www.q-med.com We want your application by February 24th at the latest.