Pharmacovigilance and medical information associate

Pierre Fabre; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading pharmaceutical and cosmetics group located in Dubai is looking for a professional to ensure continuous monitoring of product safety profiles. The responsibilities include validating vigilance deliverables, analyzing risk/benefit ratios, and crafting responses to regulatory inquiries. Candidates should be experienced in safety monitoring and have strong analytical and writing skills. The company promotes diversity and inclusion, welcoming all applicants without restriction.

Qualifications

• Experience in product safety monitoring.
• Ability to analyze risk/benefit profiles.
• Strong writing skills for regulatory responses.

Responsibilities

• Validate deliverables from vigilance teams.
• Monitor and analyze product safety profiles.
• Check for local vigilance system existence.
• Draft risk management plans.
• Respond to authority inquiries.

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 Avne Klorane Ducray Ren 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 Groups 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 Worlds 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

Assurer la surveillance continue du profil de scurit des produits en dveloppement et commercialiss :

• Valider les livrables des chargs de vigilances
• Surveiller et analyser en continu le profil de scurit demploi et le rapport bnfice/risque des produits partir des informations collectes en France et linternational
• Relire et argumenter le cas chant les paragraphes concernant la tolrance des produits dans le protocole dessais les brochures investigateurs les IMPDs les rapports dessais cliniques les dossiers dAMM
• Vrifier lexistence dun systme de vigilances local
• Rdiger les plans de gestion de risque et en assurer leur diffusion au niveau des filiales
• Rdiger les rponses toutes les questions manant des autorits
• Assurer lactivit de dtection de signal
• Analyser limpact des textes rglementaires
• Mettre jour les procdures inhrentes lactivit
• Participer aux Due diligence

Who you are

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.

Required Experience

IC