Responsable Pharmacovigilance - Pharmacovigilance Manager - CDI

Nous cherchons en URGENCE un " Responsable Pharmacovigilance pour un CDI dans un site Pharmaceutique basé en Ile - de - France. ❇ JOB DESCRIPTION : ✅ Handling of adverse events, medical inquiries and product quality complaints reported with the company products; ✅ Coordinating with the case processing team for the timely processing and submission of ICSRs; ✅ Coordinating with the quality team for the timely evaluation of product quality complaints and provide response to reporters; ✅ Coordinating with the Responsible Pharmacist and provide appropriate response to medical inquiries; ✅ Responsible to author PSURs and RMPs; ✅ Responsible to coordinate with signal management team for the potential signals identified and its monitoring; ✅ Responsible to ensure compliance of all pharmacovigilance activities like case processing, medical writing, signal detection etc.,; ✅ Responsible for creating, monitor, follow-up and closure of deviations, CAPA; ✅ Responsible to create and maintain SOPs in compliance with regulatory expectations; ✅ Responsible for document management in collaboration with quality department; ✅ Ensuring a full and prompt response to any request from the competent authorities in ✅ Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product; ✅ Providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency; ✅Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals); ✅ Responsible to implement necessary measures and comply with the GDPR expectations; ❇ QUALIFICATION : ✅ Bachelor/Master of Pharmacy/Medicine ❇ EXPERIENCE : ✅Minimum 5 years’ experience in handling Pharmacovigilance activities like case processing, PSURs, Risk Management Plans, Signal Management, etc., ✅ Handling of regulatory audits, QMS. 🔺 Qui est disponible et intéressé par ce projet ? Si vous êtes intéressé, veuillez envoyer votre CV actualisé à : [email protected]