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Director, Pharmaceutical Affairs and Chief Pharmaceutical Officer Paris France,
Posted on : 02 June 2017
Contribute to the development and implementation of the strategy of Incyte Biosciences France in: Ensuring the development of the product portfolio, Allowing the availability of the product portfolio in France (? Autorisation Temporaire d?Utilisation ? [ATU], ?Autorisation de Mise sur le March?? [AMM]?), Obtaining the reimbursement conditions (Transparency) and price in collaboration with the involved departments and according to the company goals, Guaranteeing the pharmaceutical quality of the marketed products in compliance with French regulations and laws, with international regulations and laws, with Incyte Biosciences France standard operating procedures and with Incyte group procedures. Organize the Quality system within Incyte Biosciences France in accordance with French laws and regulations and with company requirements. Organize, insure and guarantee respect of the quality commitment of Incyte Biosciences France Guarantee the pharmaceutical liability of Incyte Biosciences France as an ?Exploitant? (see definition of an Exploitant, art. R.5124-2, 3? of the French Health Public Code) and assume the role of ?Pharmacien Responsable? (Chief Pharmaceutical Officer) such as described in article R.5124-36 of the French Public Health Code and in particular: Pharmaceutical monitoring e.g. :Importation and exportation Follow-ups, including complaints management, potential recalls, etc. Monitoring distribution Pharmacovigilance Medical information Promotion : advertising and sales force training Transparency and DMOS law Activities in relation with the European staffs Duties and Responsibilities Participate to Executive Committee meetings, To ensure Certification of Pharmaceuticals Sales Reps system: quality system in relation with Referential, preparation to audits and certification, follow up of certification, To ensure the control of advertising and medical information, to validate and to submit promotional materials to French health authorities and to organize the required corrective actions when applicable, To participate in the development of the Research & Development activities including clinical trials program, To ensure enforcement of the applicable regulations for actions relating to clinical trials, To be responsible for pharmacovigilance and organize the pharmacovigilance system in France in accordance with French and European requirements and with the company internal procedures in relation with the medical department, To sign the national applications for market authorization of proprietary medicinal products if applicable, To ensure the availability of batches allocated to the French market in accordance with pharmaceutical requirements, to manage the traceability of distributed batches, to follow the customer claims and any return and to handle the batch recall if any, To ensure compliance with the Good Distribution Practices (?Bonnes pratiques de distribution?, BPD) and storage conditions, To review and to validate the packaging components of the products distributed on the French market, To be responsible for the possible management of medical samples, To organize auto inspections and audits of subcontractors to ensure quality throughout the supply chain, To ensure the training of the all involved persons and validate the training/evaluation materials created by the other departments of the subsidiary in relation with the medical department, To ensure correct running of the health authority inspections, Participate in the development of medicinal products by the company, To obtain and maintain records of the medicinal products, if applicable, To collaborate with involved departments and in accordance with the company goals, to elaborate the transparency file and note of economic interest needed to obtain reimbursement and price of the medicinal products in France, To ensure enforcement of the French required declarations: DMOS, organize nomination of a data protection officer, etc. To organize the Quality system within Incyte Biosciences France in accordance with French and company requirements, To represent the company to health authorities. Requirements Doctor in pharmacy, Specialization in regulatory affairs, economy and quality, Inscription to Section B of the French Pharmacists Society (?Conseil de l?Ordre?), 10 years of experience in an equivalent function, Excellent influencing and negotiating skills at all levels, Solution orientated with excellent problem solving skills, Perfect communication skills, Discretion & ability to handle sensitive information, Well organized, robust and reliable, Able to honor deadlines, Excellent proficiency with Office software systems (Excel, Word, PowerPoint) and Outlook, French and Scientific and technical English mandatory, Additional languages would be a plus.
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