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 office

REPORTING LINE

• General Manager (France)

ROLES AND RESPONSIBILITIES

With 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 the

medicines, products, objects as well as the corresponding storage operations;

• He/she shall ensure that the conditions of transport guarantee the proper

preservation, 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 the

European 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 Health

Products of any placing on the national market of a medicinal product which he

considers 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 /Health industry ‘s

priorities: from the early access to the innovation

o You are able to work in a regulated and complex environment in perpetual

evolution

o You are able to adapt to organizational change

o You are able to establish responsible communication between external actors

and the company

o You have a good level of operational and professional English orally and in

writing

o You have good writing and oral skills and know how to adapt your speech to

different audiences .

o You are able to write reports and synthesis notes

o You are able to identify, select, contract and manage partners .

• Profession :

o You have a vision and systemic apprehension of health issues

o You are familiar with the national and European regulations applicable to

drug products.

o You have acquired specialized expertise on all regulatory issues

o You are able to analyze and resolve complex regulatory issues

o You are able to well understand the pharmaceutical responsibility and liability

and the risk management

o You have ability to analyze the impact of change

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Experience in a pharmaceutical environment on similar activities (minimum 3 years)
• He/she holds a European diploma in pharmacy or a recognised diploma from a third country (Article R 5132-30);
• He/she is fluent in French (article R 5132-33); and English
• He/she has a validated practical experience of 6 minimum months in quality control for companies with at least one manufacturing activity or importers or in

pharmacovigilance and batch monitoring for companies with operator activities only.

#LI-Onsite

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The annual base salary hiring range for this position is €88,000.00 - €121,000.00 EUR

This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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