VIE Suède- Chargé(e) Pharmacovigilance et Assurance Qualité

Job description

Who we are ?

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care. 

Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. 

In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.

Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide. 

Your mission

Nous recrutons pour 1 an au sein de notre filiale suédoise PIERRE FABRE MEDICAMENT à Stockholm, et sous la responsabilité du Directeur QRVI, un(e) VIE LOCAL SAFETY OFFICER / QUALITY ASSURANCE OFFICER qui participera aux activités quotidiennes du département Assurance Qualité, Affaires Réglementaires, Pharmacovigilance et Information Médicale (QRVI) de la région nordique (comprenant la Suède, le Danemark, l'Islande, la Norvège et la Finlande) pour les médicaments et les dispositifs médicaux commercialisés localement par Pierre Fabre, conformément aux directives de l'entreprise et aux exigences locales.

Missions principales :

Pharmacovigilance :

- Gérer les cas locaux de pharmacovigilance (PV) provenant de toutes les sources pertinentes (collecte, enregistrement, documentation/enquête avec les déclarants, analyse des informations recueillies, évaluation de la causalité le cas échéant, clôture); transmettre au département de vigilance de l'entreprise (CCD) et rapporter aux autorités sanitaires locales conformément aux réglementations locales.

- Effectuer un examen périodique des demandes d'informations médicales et des plaintes relatives à la qualité des produits afin d'identifier les cas potentiels de PV associés.

- Assurer la supervision du plan de gestion des risques et de la mise en œuvre des mesures de minimisation des risques en collaboration avec le personnel concerné, conformément aux exigences de la CVD et des autorités réglementaires locales.

- Participer à la négociation et à la rédaction de l'accord d'échange de données de sécurité (SDEA) avec les partenaires locaux. Veiller au respect des accords inclus dans l'accord d'échange de données de sécurité.

Assurance de la qualité :

- Gérer les réclamations relatives à la qualité des produits de l'entreprise, conformément au système de gestion de l'AQ.

- Gérer les déviations et les contrôles des changements conformément au système de gestion de l'assurance de la qualité.

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As part of our Nordic affiliate, Pierre Fabre Pharma Norden AB (PFPN), and under the responsibility of the Nordic QRVI Director, you will participate in the daily activities of the Quality Assurance, Regulatory Affairs, Pharmacovigilance and Medical Information (QRVI) department of the Nordic area (including Sweden, Denmark, Iceland, Norway and Finland) for the medicinal products and medical devices marketed locally by Pierre Fabre according to corporate guidelines and local requirements. The position is located in Stockholm.

Main missions:

Pharmacovigilance:

·  Management of local post-marketing cases from all relevant sources: collection, recording, documentation/investigation with reporters, analysis of the collected information, causality assessment if applicable, closure; transmission to Corporate Vigilance Department (CCD) and reporting to local Health Authorities according to local regulations.
·  Performs a periodic review of Medical Information (MI) requests and Product Quality Complaints (PQC) in order to identify potential associated PV cases
·  Ensures oversight of Risk Management Plan and Risk Minimisation Measures implementation in collaboration with relevant staff in accordance with CVD and local regulatory authority requirements.
·  Participates to the negotiation and writing of Safety Data Exchange Agreement (SDEA) with local partners. Ensures compliance with agreements included in the SDEA.

Quality Assurance:

·  Management of Product Quality Complaints linked to the Corporate QA complaints according to the QA management system
·  Management of Deviations and Change Controls according to the QA management system

Who you are ?

Formation scientifique pertinente, de préférence Master Pharma ou Pharm D.

Une formation complémentaire en pharmacovigilance est souhaitée.

Expérience d'1 an ou 2 en pharmacovigilance dans l'industrie pharmaceutique (produits médicinaux).

Connaissance acquise des bases de données PV (ARGUS LAM) de préférence.

Maîtrise de l'anglais.

Habitué à travailler de manière autonome et à faire face à des situations complexes.

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·  Relevant education in sciences, preferably MSc Pharmacy or Pharm D. Additional education in Pharmacovigilance is preferred.
·  1-year experience within Pharmacovigilance in the pharmaceutical industry (medicinal products).
·  Acquired knowledge of PV databases (ARGUS LAM) is preferred.
·  Fluent in English.
·  Accustomed to working independently and dealing with complex situations.

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.