Local responsible person for
West Gate Drugstore
Total des années d'expérience :1 years, 10 Mois
regulatoryaffairs pharmacist. Regulatory Affairs Quality Assurance LRPPV Thorough understanding and working knowledge of regulatory submissions and requirements. Quality Assurance training- Edwards Lifesciences, Switzerland Basics of Pharmacovigilance for LRPPV training course Guerbet, France Managing Post Approval Activities (PAC) Managing external quality audits. PV activities Excellent and effective follow up with key persons at health authorities. QMS, change control, SOPs creation and reviewing. Maintain effective PSSF, SOPs, logbooks, forms and indexes. Assuring shipments importation according to authority approved specifications. RCA and CAPA implementation for non conformities & recall process. Managing (MAHs) external audits in detail.
•June 12, 2022: Pharmacovigilance Training Course- IQTERAN company