Deputy Responsible Pharmacist
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. PURPOSE OF THE FUNCTION• Takes the role and responsibilities of the Responsible Pharmacist when he/she is out of the officeREPORTING LINE• General Manager (France)ROLES AND RESPONSIBILITIESWith a view to the application of the rules enacted in the interest of public health, the Responsible Pharmacist defined in Article R. 5124-34 shall carry out the following tasks insofar as they correspond to the activities of the company or body in which he/she carries out:• He/she organizes and supervises all the pharmaceutical operations of the company,and in particular the manufacture, advertising, information, pharmacovigilance,monitoring and withdrawal of batches, distribution, import and export of themedicines, products, objects as well as the corresponding storage operations;• He/she shall ensure that the conditions of transport guarantee the properpreservation, integrity and safety of such medicines;• He/she signs, after having read the file, the applications for marketing authorization submitted by the company;• He/she participates in the development of the research and study program;• He/she has authority over the delegated and deputy pharmacists; he/she gives his approval to their appointment and is consulted on their dismissal;• He/she designates the interim delegate pharmacists;• He/she shall inform the other managers of the company or body of any obstacle or limitation to the exercise of these powers;• He/she shall take all necessary measures to ensure compliance with the obligations provided for in Articles R. 5124-48 and R. 5124-48-1;• In the case of medicinal products intended to be placed on the market in theEuropean Union, he/she shall ensure that the safety devices referred to in Article R.5121-138-1 have been affixed to the packaging under the conditions laid down in Articles R. 5121-138-1 to R. 5121-138-4;• He/she shall notify the National Agency for the Safety of Medicines and HealthProducts of any placing on the national market of a medicinal product which heconsiders falsified within the meaning of the provisions of Article L. 5111-3, of which he is responsible for the manufacture, exploitation and distribution.SKILLS AND COMPETENCIES• Transverses:o You have a global vision of the pharmaceutical Industry /...