Senior Director, Responsible Pharmacist (Pharmacien Responsable), France

About the role

General Purpose The Senior Director, Head Pharmacist/Responsible Pharmacist guarantees the pharmaceutical responsibility of the laboratory as "exploitant" (see definition of the "exploitant", Article R.5124-2, 3 ° of the French Public Health Code) and assumes the role of "Responsible Pharmacist" as described in Article R.5124-36 of the Public Health Code. Responsibilities include: Organize and supervise all pharmaceutical operations of the company or organization, including manufacturing, advertising, information, pharmacovigilance, batch monitoring and withdrawal, distribution, import and export of the drugs, products, objects or articles concerned, as well as the corresponding storage operations. Ensure that transport conditions guarantee the proper preservation, integrity and safety of these medicines, products, objects or articles. Acknowledge the files related to marketing authorization applications submitted by Corporate or organization and any other application related to the activities they organize and supervise. Participate in the development of research and study programs. Imperson authority over delegate and deputy pharmacists; approve their hiring and be consulted on their dismissal, except in the case of an army pharmacist-chemist. Appoint interim delegate pharmacists. Inform the other directors of the company or organization of any obstacle or limitation to the exercise of these powers. Implement all necessary means to comply with the obligations set out in articles R. 5124-48 and R. 5124-48-1; In the case of medicinal products intended to be marketed in the territory, he(she) ensures that the safety measures referred to in article R. 5121-138-1 have been affixed to the packaging in accordance with the conditions set out in articles R. 5121-138-1 to R. 5121-138-4; Notify the Agence nationale de sécurité du médicament et des produits de santé (ANSM : French National Agency for the Safety of Medicines and Health Products) of any launching on the national market of a medicinal product which is considered to be falsified within the provisions of article L. 5111-3, and for which they are responsible for the manufacture, exploitation and distribution. They organize the quality system within the laboratory in accordance with French laws and regulations (good distribution practices, good pharmacovigilance practices, good manufacturing practices) and laboratory requirements. They also support the transversal activities carried out by the marketing, medical, compliance and market access departments. The Senior Director, Head Pharmacist/Responsible Pharmacist, France takes part in the deliberations of the management, administrative, executive or supervisory bodies, or those of any other body with an executive function, of the company or organization, when these deliberations concern or may affect the performance of the tasks falling under his/her responsibility as described above. The RP is responsible for ensuring compliance with professional ethics and all regulations issued in the interests of public health. He/she must also ensure that the responsibilities of pharmacists and staff under his/her authority are clearly defined. In accordance with articles L. 5121-14-3, R. 5121-152 and L. 5121-164 of the French Public Health Code, the RP ensures that pharmacovigilance cases are reviewed and processed within the appropriate timeframes. In accordance with article L5121-9-2 of the French Public Health Code, the RP immediately informs the French National Agency for the Safety of Medicines and Health Products of any prohibition or restriction imposed by the competent authority of any country in which the medicinal product for human use is marketed, and of any other new information likely to influence the evaluation of the benefits and risks of the medicinal product for human use or the product concerned. In addition, the Responsible Pharmacist also has knowledge of : the role of professional bodies and organizations that regulate those who supply medical products to the public. the ANSM's role in handling controlled drugs. the role of the European Medicines Agency (EMA) and the use of EUDRAGMDP. the Directive on Falsified