Nawal Jebbar | Lead, Safety and Pharmacovigilance, EMEA & EU QPPV
Amylyx Pharmaceuticals

Experienced QPPV and GPV auditor, performing audits of central PV functions, Provides guidance and support in setting-up PV systems, and advice on strategy and processes. Undertakes reviews of procedures and systems...Since 2011, working in different departments such as Quality Assurance, RA, Pharmacovigilance as EMA certified European Qualified Person for Pharmacovigilance (QPPV), Medical Advisor being the global head of Medical Affairs & PV auditor and compliance expert in several big and medium sizes Pharma such as: Bayer, Merck, Pharmex Advanced Laboratories. S.L, DBV Technologies, Stada (Lobsor), etc. I’ve to ensure the correct performance and quality system of the pharmacovigilance / Medical Affairs / Safety department, Establishing and maintaining the PV system; acting as Qualified Person responsible for Pharmacovigilance (QPPV) and PV global lead for several pharmaceutical laboratories, which I’m the head of the pharmacovigilance department since they’ve outsourced it to service providers such as; the Swedish CRO TFS, the American multinational consulting Alphanumeric, or ProPharma Group Netherlands B.V. working for either for medium size companies or big pharma companies such as Stada, Johnson & Johnson, Merck, Sanofi, etc. To sum up, with more than 12 years’ experience globally in cross-functional departments; QA, RA, BD  PV / Drug safety, GVP/GMP compliance & GVP/GMP Audits/Inspections, and market research, leading SMEs in the following:  1. A Quality Management System (QMS) set up: is including audits & inspections readiness, Corrective Action, Preventive Action plans (CAPAs) monitoring and implementation FU assessment… 2.Risk Management Plans (RMPs), Business Continuity Plans, PSURs, ICSRs, aggregate reports, Post-Authorization Safety Studies (PASS) and other safety reports, Signal detection and safety trending. All suspected adverse drug reactions ADRs are collected and collated and accessible at one or more points in the EU. 3. Site Master File, Quality manual & Pharmacovigilance System Master File (PSMF) is in place, accurate and up to date. On the other hand, I’ve been also been lucky to be nominated and to take part of diverse, international and cross functional leadership teams such as; international business / regulatory team, performing the review and set up pharma company in new territories starting from site registration, tender preparation until specific clinical/scientific requirements of dossiers for specific territories in EMEA, APAC, US and Canada. 1. Associate Manager / QP for international strategy for Market & Business Development (International BD), market research strategy, QA & compliance, and operations team. 2.Global Pharmacovigilance / Medical Lead, compliance Auditor and Manager of PV & Quality: Clinical Trials management and planning: leading cross-functional global teams involved in several CTs with different stages & phases. 3. Market strategy and Company Gap Analysis responsible: identifying and communicating potential gaps in current cross-departmental processes and organizational structures and work with other line management to remove obstacles to effective project execution. Proactively recommending and outlining new processes for upcoming and current clinical development phases through integration of new technologies into the team and setting appropriate processes to drive more clarity and efficiency globally. 4. EMEA & APAC Operations Manager: from 2020, I’ve been appointed Operations Manager and lead for J&J COVID-vaccine in EMEA and APAC regions leading a team of aprox. 100 persons.