Zahra Hassan Hussein Sobhy

Regulatory Affairs Pharmaco-Vigilance Manager

Address: Dubai, UAE Phone: +971-********* Email: ad0wp6@r.postjobfree.com Nationality: Egyptian LinkedIn: Zahra Sobhy

Summary

A dedicated and professional Regulatory Affairs & Pharmaco-Vigilance Manager with 16+ years of experience in the pharmaceutical industry. Proven record of effectively applying skills and experience for regulatory and PV strategic plans overcoming technical issues for brands geographical expansions across the whole META region and SSA markets. Effective leader who performs well in collaborative environment with managers, clients and coworkers. Adept at event monitoring, reviewing, analyzing and preparation of reports. Seeking to work in an environment that is conducive to my intellectual, professional, and personal growth, where I can contribute significantly to the growth of the team/organization with strong experience and expertise leading to success. Experience

QA/Regulatory Affairs & Pharmaco-Vigilance Manager – 12/2016 to Present Fidia Farmacutici, Dubai, UAE

Prepare, review, analyze and consolidate all relevant and related technical information for the approval/licensing of products CTD/eCTD/CMC, and dossier for MD for MAAS while being responsible for the timely completion of regulatory submissions, renewals, variations, and related amendments with the competent authorities

Provide strategic planning and implement the AW harmonization project across the whole META region, manage the pricing issues with HA, and conduct price appeals and meetings if requested while implementing training for the regulatory HQ team to keep up to date of the META region regulations that will be aligned together

Manage and support the tracking/tracing system implementation for pharmaceutical products, 2DMATRIX, GS1Serialization, Aggregation, Brand Synchronization, MVC, Tatmeen system, SSCC, SGTIN while collaborating with HQ Regulatory Team, as well as Supply Chain Management to innovatively address regulatory issues and support achievement of Regulatory Compliance

Handle and process quality market complaints as per the company SOPS while planning site audits documents in collaboration with quality department, as per GXP,GMP, ISO 9001, ISO 13485 attending the audits, helping with the audits report to be as per META region HA format, and handling the findings CAPAs, reporting to SAP

Collaborate with Marketing/division managers, quality, and medical affairs to assess and prioritize submissions to competent authorities, and set the product launch strategic plan with marketing department while keeping up to date on new and proposed regulations and guidelines published by HA

Manage and actively update the registration tracker database, and document all products approved for sale in the region to ensure the accuracy of the information and related change initiatives

Lead and/or conduct proactive Pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans

Manage the routine PV documents submission, PSUR, PBRER, ICSR, ADRs, HPCS, national PSSFs, global and local RMPs, PV templates, declarations and SMHs

Implement local PV SOPs with the guidance of the global SOPs as per the common Arab Guidelines for Pharmacovigilance while preparing and performing duties as a Safety Strategy and Management Team (Sat) leader

Collaborate with the head-quarter and Clinical representatives, and author the Reference Safety Information

(RSI) for assigned development products while coordinating meetings and tracking timeliness to ensure completion

Pro-actively evaluate the clinical implications of safety data from per-clinical studies, clinical studies, literature, and other information sources to establish the safety profile of drugs and manage the risk to patients while implementing, designing, and conducting Pharmacovigilance trappings

Achieve geographical expansion with 2 new therapeutic lines and 20 new products registration with their PV activities across the META region

QA/Regulatory Affairs & Pharmacovigilance Manager – 12/2015 to 11/2016 Paul Hartmann, Dubai, UAE

Ensured that company's products complied with the regulations of the META region while preparing submission dossiers, CTD/eCTD, and technical MD dossiers submissions

Kept up to date with international and META region legislation and guidelines for products registrations, renewals, and variations as per each country legislation while developing and writing clear arguments and explanations for new product licenses and license renewals

Managed products’ classification conflicts and proceeded with medical devices classified as pharmaceuticals if decided by the HA while managing AWS ensuring compliance with META region HA requirements

Provided strategic advice to senior management throughout the development of a new product while collaborating with quality, medical affairs for the technical SPECS and Analysis SPECS of products and handling quality complaints

Planned for products launches with the marketing department and area managers as per the registration plan, providing them with approved brochures as per HA legislation while negotiating with regulatory authorities for marketing authorization

Specified storage, labeling, packaging requirements, and data loggers while preparing audit documents, attending audits, and helping with audit report and its findings, CAPA if any, as per HA regulations

Organized, managed, and maintained a highly compliant Pharmacovigilance (PV) system across the META region with distributors while keeping an eye on the updates of both global and local PV guidelines to ensure best PV practices, PV business continuity, and after-hours availability

Led and coordinated internal PV audits and inspections across the META region, and monitored the PV system performance and compliance of partners and distributors while being accountable for all PV activities in the META region

Managed the routine PV documents submission, PSUR, PBRER, ICSR, ADRs, HPCS, national PSSFs, global and local RMPs, and implemented local PV SOPs with the guidance of the global SOPs as per the common Arab Guidelines for Pharmacovigilance while planning local RMPs as per the countries in the META region that mandate it, in addition to the global RMP

Acted as the responsible contact person in the region, internally, for safety-related aspects and PV while ensuring the internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities

Achieved geographical expansion with 1 new therapeutic line and 10 new products registration with their PV activities across the META region

QA/Regulatory & Pharmacovigilance Manager – 10/2013 to 11/2015 Egyptian International Pharmaceutical Company “EIPICO”, Dubai, UAE

Ensured that the company's products complied with the regulations of the Medicines and Healthcare products Regulatory Agency while providing dossier submissions CTD/eCTD

Kept abreast of international legislation, guidelines, and customer practices in all countries that the company was exporting to in order to pack management activities including compliance to local Labelling Requirements and processing pack changes when necessary.

Oversaw the reviews and approvals of promotional materials to provide regulatory input and guidance across the Affiliate, and obtain Regulatory Authorities' clearance when necessary

Provided oversight of shipment clearance/QA release of Affiliate materials/products while supporting local market access activities from a regulatory perspective

Monitored and set timelines for license variations and renewal approvals while undertaking and managing regulatory inspections, reviewing company practices, and providing advice on system changes

Managed pricing conflicts, and conducted price appeals and meetings upon request while performing Individual Case Safety Report (ICSR) quality control (QC) Close processed ICSRs, and reporting spontaneous ICSRS to Health Authority

Reported Suspected Unexpected Serious Adverse Reactions to Health Authorities, ECs and investigators - create a hard copy template for the PV Associate to adapt and distribute while performing ICSR reconciliation with business partners, and tracking ICSRs

Wrote and contributed to PSURs and ASRs as required through acting as the project coordinator while collating the needed information, incorporating reviewers' comments and finalizing the document

Assisted with Pharmacovigilance processes, supported the preparation of SOPs, product safety reviews and literature reviews as required, while reviewing literature screening search results, identifying ICSRs and other safety-related findings, and preparing HCPs letters as per safety issues of the products

Achieved geographical expansion with new 11 products registration with their PV activities and Tenders management across the META region

Medical Representative – 04/2012 to 08/2013

Badr Sultan and Bothers Company, Safat, Kuwait, Dubai, UAE

Networked expansion with the KOLs while presenting to doctors, practice staff and nurses in aesthetic clinics and centers, managing budgets (for catering, outside speakers, conferences, hospitality, etc.), and keeping detailed records of all contacts

Reached (and if possible, exceeded) annual sales targets while planning work schedules, and weekly / monthly timetables

Kept up to date with the latest clinical data supplied by the company while interpreting, presenting, and discussing this data with health professionals during presentations

Monitored competitor activity and competitors' products, provided SKU management while setting up a scientific office in Dubai

Developed an in-depth understanding of company medications while building and maintaining good business relationships with customers to encourage repeat purchases

Followed up on leads generated by the company, and prepared presentations for potential customers while researching competitor’s medications and their respective market performances

Achieved 8 new accounts opening for products in Dubai, with governmental and private institutions Key Account Manager & Regulatory Affairs Officer – 02/2010 to 02/2012 Yomaya Medical Trading, UAE, KSA

Medical Market Researcher & Analyst – 01/2008 to 01/2010 IPSOS Company for Medical Research, Dubai, UAE

Pharmacist – 09/2005 to 11/2006

Dr. Mamdooh Al-Morshed Pharmacy, Cairo, Egypt

Research Analyst – 06/2004 to 10/2004

Pharma Dynamics Company, Cairo, Egypt

Medical Representative Training – 06/2004 to 09/2004 Boheringer Angelhiem Drug Company, Cairo, Egypt

Education

Master of Science in Pharmaco-Economics – Present

Barcelona School of Business, Barcelona, Spain

Master of Science in Pharmacovigilance – 2020

Bordeaux University, Bordeaux, France

Master of Business Administration – 2013

Chiffley Business School, Australia

Master of Science in Pharmacology and Toxicology – 2013 UAE University, AL Ain, UAE

Bachelor of Science in Pharmacy – 2005

Ain Shams University, Cairo, Egypt

Affiliations

RAP Society of the USA

Skills & Expertise

Team Management

Communication & Negotiations

Problem Solving

Troubleshooting

Organizational, Facilitation & Interpersonal

Skills

Knowledge of the Pharmacovigilance

Regulations in the META Region & Europe

Analytical Skills

Employee Training

Negotiations & Contracts

Policies & Procedures

Selling Techniques & Strategies

Microsoft Office

National & regional Regulatory Legislation &

Guidelines

Rational Approach to Issues and their

Business Implications

Languages

Arabic: Native English: Fluent

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