Associate Manager Drug Safety and Risk Management Middle East and North Africa
Celgene
مجموع سنوات الخبرة :7 years, 2 أشهر
Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options
Lead of the Local Drug Safety Office for Middle East and North Africa
Legislation scanning for Arab countries
Adverse events receipt, follow up and submission to local Health Authorities
Training on Drug Safety and Risk Management
Oversight of Business Partners Pharmacovigilance contracts and agreements
Set up and update of Risk Minimization Plans (RMinPs)
Contact point for Global Drug Safety and Clinical Research Organizations for Safety reporting in local clinical trials
Oversight of Medical information and Quality Complaints flow
Quality Management System set up and maintenance
Preparation of audit and implementation of CAPAs
Support in the application of the new Guideline on Good Pharmacovigilance Practices (GVP) for Arab countries
Danone is one of the world’s leading food company built on four business lines: fresh dairy products, waters, early Life nutrition and medical nutrition
Implementation of the digital strategy
Sales analysis and monitoring of monthly performances
Creation of promotional materials and coordination with suppliers and communication agencies
MacoPharma is one of the leading global players in infusion, transfusion and biotherapy systems (Head Office in France)
• Implementation of the pharmacovigilance system
• Maintaining the PSMF (Pharmacovigilance System Master File) up to date
• Regulatory and scientific monitoring
• Management of the pharmacovigilance and medical devices vigilance cases (including analysis, evaluation and submission to authorities)
• Management of safety reports and submission to authorities (periodic safety update reports and risk management plans)
• Training of sales forces in terms of regulatory and vigilance requirements
• Management of the standard operating procedures and the work instructions
• Conducting internal audits and management of the inspections held by the European Authorities
• Conducting audits of distributors outside Europe
• Conducting audits of departments concerned by pharmacovigilance activities
• Follow up deviations, corrective and preventive actions and key performance indicators
• Project Manager for the implementation of the vigilance database including the validation and the creation of the correspondent procedures
• Management of SDEA (Safety Data Exchange Agreement) with the distributors
- Pharmacovigilance cases analyses
- Signal Detection
- Management of Standard Operating Procedures
6 months internship (Master 2) " Anti-cancer effect of FL3, the first synthetized flavagline"
- Cell Culture
- Western Blot
- Flow cytometry « FACScan »)
3 months internship (Master 1): Valorisation of glycerol and its derivatives:
- Nuclear magnetic resonance (NMR)
- high performance liquid chromatography (HPLC))
- Market research - Influence strategy (role of medical representative) - Marketing by numbers (market share, selling price, margin, etc…) - Business strategy - Project Management - Distribution of health products - Finance, diagnosis and business plan - Role of the product Manager - Human ressources - Promotion
Master 2 in pharmacology - Faculty of pharmacy, Strasbourg, France
2008-2009: Master 1 in Chemistry and Biology " Drugs and natural substances " - Faculty of Science, Reims, France
2005-2008: Bachelor in biochemistry, Faculty of Science, Lebanese University, Beirut, Lebanon
2004-2005: Baccalaureate of Science (Life Science), Saida, Lebanon