Ashwaq Mukaram, Regulatory Affairs Manager

Ashwaq Mukaram

Regulatory Affairs Manager

شفاكو للصناعات الدوائية

Location
Yemen
Education
Master's degree, ادارة اعمال
Experience
15 years, 3 Months

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Work Experience

Total years of experience :15 years, 3 Months

Regulatory Affairs Manager at شفاكو للصناعات الدوائية
  • Yemen - Sanaa
  • My current job since February 2009

' Establishing and maintaining a pharmacovigilance system.
' Preparing pharmacovigilance reports as defined by regulations.
' Answering requests from Health Authorities.
' Providing Health Authorities with any other information relevant to product
safety.
' Establishing and maintaining/managing the pharmaceutical company's
pharmacovigilance system.
' Having an overview of the safety profiles and any emerging safety concerns
for the company's drugs.
' Acting as a single contact point for the Health Authorities on a 24-hour basis

scientific information department at shaphaco Pharmacist Industry
  • Kuwait - Al Kuwait
  • January 2014 to January 2022

Education

Master's degree, ادارة اعمال
  • at الاكاديمية للدرسات العليا
  • December 2023

الرسالة البوابة الالكترونية بين الحكومة و الشركات

Bachelor's degree, صيدلة
  • at كلية الصيدلة
  • May 2005

Bachelor of Pharmacy : Pharmaceutical science, Sana'a University -2005

Specialties & Skills

Registration
Pharmacist
Marketing
Regulatory Affairs
العلاقات العامة الجيدة مع الدول المختلفة
Risk Management
Registration
Microsoft PowerPoint
Problem Solving
Quality Assurance
Pharmaceuticals
Marketing
Compliance Management
Legal Compliance
Pharmacovigilance
Pharmaceutical Research
Pharmacists
الابتكار و الابداع
Microsoft
Regulatory Affairs

Social Profiles

Languages

Arabic
Native Speaker
English
Expert

Memberships

shaphaco pharmaceutical industry
  • regulatory manager
  • January 2009

Training and Certifications

SPSS (Certificate)
Date Attended:
October 2023
eCTD (Certificate)
Date Attended:
October 2022
TOT (Certificate)
Date Attended:
January 2016
A training course in pharmacovigilance system (Training)
Training Institute:
Supreme Board of drugs & Medical Appliances.
Date Attended:
January 2022
Duration:
12 hours

Hobbies

  • البحث العلمي
  • التطوير و التكنولوجيا
    CTD System ,ECTD System