Senior (Advanced) Safety Officer
Tasks AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV), non-interventional studies and post-marketing activities. Our offices are located in France, Denmark, Switzerland, Belgium, Germany and the Czech Republic.We are currently looking for a Senior (Advanced) Safety Officer, who will ensure the good performance of post-marketing pharmacovigilance project, which is entrusted to him, in accordance with the specifications contracted with customers, in compliance with regulations, ethics, quality and compliance with procedures and deadlines.This includes, but is not limited to:Main Responsibilities:Manage a project as Project Manager, provides a priority interface with the client, supports the development of SDEAs, tools and documents for this project and their implementations, supports Billing and Financial Status development, establishes Workplans, participates in Client Meetings and proposes, if needed, any improvement solutionManagement of Adverse Events for assigned project, in accordance with applicable regulations and proceduresGlobal and Local literature survey concerning the entrusted products and the corresponding pathologiesParticipation in monitoring of regulation for Vigilance activities (pre- and post-marketing);Preparation of Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Addendum of Clinical Overview (ACO), Signal detectionParticipate in preparation and attendance of audits and inspections, as well as in the implementation of corrective or preventive action of CAPAsTheoretical knowledge and practical skills in MedDRA and WHO DD codingParticipation in definition of human resources needs for the projects on which he is assigned in consultation with the Head of the departmen Requirements Senior Safety Officers should have:A university degree in Pharmacy, health science, medicine or a related discipline4 to 6 years of relevant experience in pharmacovigilance;Experience of work in multinational companyGood knowledge of the regulations (GVP, ICH, GCP) and tools related to the activity (databases, Eudravigilance)We are seeking candidates who possess, among other skills, the following: Autonomy and a sense of responsibilityAnalytical and synthesis skillsAbility to use simple language based on target audienceProject team coordinationAbility to keep tight deadlines and work under pressureAbility to inspire confidence and mutual respectExcellent communication skills with different internal and external stakeholdersFluency in English (French as advantage)Scientific expertiseVersatilityMeticulousness and attention to detailPlanning skills and organized work habitsWe provide:An opportunity to work in international teamAn attractive finance bonuses according to a good resultYoung and friendly team25 days of holiday per year (instead of the standard 20 as per Czech law)Pleasant offices in the center of Brno or PragueA possibility of professional courses and international conferencesMeal vouchers (95 CZK per worked day, 55% covered by the company)Language trainings (EN, DE, FR, ES or CZ)Multisport card (fully paid by the company)