Marwa Zaki, QPPV, Regulatory Affairs and Quality Manager

Marwa Zaki

QPPV, Regulatory Affairs and Quality Manager

Advanced Technology Company

Location
Kuwait - Hawali
Education
Bachelor's degree, Faculty of pharmacy
Experience
6 years, 5 Months

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Work Experience

Total years of experience :6 years, 5 Months

QPPV, Regulatory Affairs and Quality Manager at Advanced Technology Company
  • Kuwait - Hawali
  • My current job since November 2019

Experience in Regulatory, pharmacovigilance, pricing and quality

Pharmacovigilance Safety Expert at Bahrain Pharma Egypt
  • Egypt - Cairo
  • July 2016 to April 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.

Education

Bachelor's degree, Faculty of pharmacy
  • at Helwan university
  • June 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

Languages

English
Intermediate

Memberships

International Society of Pharmacovigilance
  • Member
  • August 2021

Training and Certifications

Gcc pharmacovigilance (Certificate)

Hobbies

  • Swimming