Head of Global Safety Product Leads PV Operations & Trial Management (m/f/d) in Freiburg im Breisgau, Unterensingen

As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Head of Global Safety Product Leads PV Operations & Trial Management (m/f/d) Your tasksTeam management of a group of Global Safety Product Leads acting also as Business Process Owners for PV Operations & Trial Management including leading, mentoring, and developing a team of Global Safety Product Leads, fostering a culture of compliance and excellence.Ensuring takeover of the following tasks and responsibilities of the Global Safety Product Leads group:Global pharmacovigilance product responsibility for the medicinal productsMonitoring of the benefit-risk profileSignal management: signal detection, signal validation, signal evaluationRisk management: preparation of risk management plans, supervision of risk minimization measuresPreparation of periodic safety reportsSupervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documentsMaintenance and shaping of the processes regarding PV Operations (especially case processing and associated topics) and Trial Management (especially clinical safety related documents and reporting)Supporting the Head of Global Safety / EU/UK QPPV / Graduated Plan Officer in the fulfillment of pharmacovigilance obligationsResponsibility as Deputy Graduated Plan Officer according to63a AMG in absence of the Graduated Plan OfficerResponsibility as Deputy EU/UK QPPV in absence of the EU/UK QPPVResponsibility As Global Safety PhysicianAvailable to QPPV to discuss medical issues in form of a 24/7 on call system as requiredReview of safety relevant data in clinical trials or for marketed medicinal productsReview of adverse events as required and assessment of their severity, causality and expectednessParticipation in drug safety review committees (i.e. patient safety committee) and provision of medical expertise. This task includes the definition and triggering of suitable risk minimization measures in case new safety signals are detected.Your benefitsSupportive, respectful and appreciative work atmosphere in a small, dedicated teamDiverse learning culture and individual development opportunitiesInternational and growing family business with short decision-making processes, financial independence and long-term perspectiveNew work, flexible working hours and mobile workingWide range of benefits (free beverages, health and sports benefits, canteen, JobRad)Comprehensive onboarding and mentoring programIn addition to adequate remuneration, we offer a secure and interesting job in a competent and open-minded team. If you have any questions, please do not hesitate to call Sabine Aicher at 0761 1514-253. Your contact: Personnel department Dr. Falk Pharma GmbH Leinenweberstraße 5 79108 Freiburg im Breisgau #J-18808-Ljbffr