مروة زكي, QPPV, Regulatory Affairs and Quality Manager

مروة زكي

QPPV, Regulatory Affairs and Quality Manager

Advanced Technology Company

البلد
الكويت - حولي
التعليم
بكالوريوس, Faculty of pharmacy
الخبرات
6 years, 4 أشهر

مشاركة سيرتي الذاتية

حظر المستخدم


الخبرة العملية

مجموع سنوات الخبرة :6 years, 4 أشهر

QPPV, Regulatory Affairs and Quality Manager في Advanced Technology Company
  • الكويت - حولي
  • أشغل هذه الوظيفة منذ نوفمبر 2019

Experience in Regulatory, pharmacovigilance, pricing and quality

Pharmacovigilance Safety Expert في Bahrain Pharma Egypt
  • مصر - القاهرة
  • يوليو 2016 إلى أبريل 2018

Qualifications
extensive knowledge of Pharmacovigilance regulations and have strong leadership, communication, and problem-solving skills, along with a demonstrated ability to build and manage close relationships with colleagues in businesses. Experience interacting with auditors / inspectors and conducting qualification audits is a plus. Major Activities and Responsibilities  Responsible for ensuring training and development is disseminated throughout PV Personal. This is achieved by working with PV teams to ensure there is a compliant training plan in place.
 Responsible for identifying any PV skills, knowledge or resource gaps and proposing solutions to correct any defecits.  Responsible for ensuring compliance with MOH policies and procedures in relation to PV.
 Responsible for assisting markets in preparation and response to formal audits.

الخلفية التعليمية

بكالوريوس, Faculty of pharmacy
  • في Helwan university
  • يونيو 2006

 B. pharm degree , from faculty of pharmacy , Helwan University.  Total Grade : Good  Year Of Graduation : 2006.

Specialties & Skills

PV Intelligence - knowledge of pharmacovigilance systems & requirements - knowledge of pharmacovigilance principles, concepts, practices & standards - in depth knowledge of the local country(ies) pharmacovigilance regulations & obligations - understanding of risk management - Knowledge local country(ies) industry code(s) of practice People Management - ability to identify talent and develop direct reports - ability to coach and motivate those undertaking PV activities - ability to manage performance of direct reports

اللغات

الانجليزية
متوسط

العضويات

International Society of Pharmacovigilance
  • Member
  • August 2021

التدريب و الشهادات

Gcc pharmacovigilance (الشهادة)

الهوايات

  • Swimming