Doha Youssry Zaky Elsakka.

Address: * ***** *******, **, *****, Giza, Egypt.

E - mail : adbt40@r.postjobfree.com

Mobile no.: 002***********

Phone no.: 02 33363969

Career Objective:

Seeking new opportunity where I can expand my horizon and develop new skills while contributing with my knowledge and experience gained in the field of Pharmaceuticals. Education:

Pharmacovigilance waves by Egyptian Pharmacovigilance Center MOH and Arab union of Manufacturers of Pharmaceutical Appliances the new Harmonized Arab guidelines for Pharmacovigilance. (Year: 2016).

MOH emirates license (Year: 2014).

Premaster in pharmaceutical chemistry: Ain Shams University (Egypt),Year : 2010.

Bachelor of pharmacy (new system) Cairo University (Egypt).Graduation year :2008 Cumulative grade: Very good with honor rank.

High school: International general certificate secondary education (IGCSE) Cambridge University First year: Education home school

Second two years: Manor house school.

Cumulative grade: A

Preparatory and primary school: New Orouba language school (Dokki)(Egypt). Work Experience:

November 2018 till now (Ongoing): Regulatory affairs supervisor at Alandalous Medical Company (Egypt)

· Preparing, submitting and getting approvals for variations files ( composition change, addition of supplier, PH change, Supplier name changes) for medicinal products.

· Responsible for getting approvals of materials transfer between Al Andalous factory and other manufacturing sites.

· Revising promotional and educational material before submitting to Central Administration of Pharmaceutical Affairs for approval to ensure compliance with their regulations.

· Preparation and submitting the required files for approvals of promotional and educational material (New files, Extensions and derivatives) to Central Administration of Pharmaceutical Affairs .

· Follow up and complying of comments of Central Administration Of Pharmaceutical Affairs for the submitted promotional and educational materials to gain approvals.

· Assist product managers in solving any emerging problems related to promotional and educational material of the company with CAPA (Central Administration of Pharmaceutical Affairs).

· Revising and giving approvals for internal promotional material and reminders.

March 2018 till now (Ongoing): Qualified person for pharmacovigilance (QPPV) and pharmacovigilance manager at Alandalous Medical Company (Egypt)

March 2016 till March 2018 : Back up and Senior Pharmacovigilance associate at Alandalous Medical Company (Egypt)

Job description:

· Process Individual Case Safety Reports (ICSRs), including data entry in safety drug database using the MedDRA coding and reporting XML files.

· Follow-up ICSRs with the reporter, assess, evaluate and report to authority.

· Performing literature searches and obtaining literature articles and reviews, to guarantee up to date information.

· Prepare PBRER as routine submission as per EURD list and on emerging safety issues.

· Preparing RMP as per registration procedures, on emerging safety issues and re- registration procedures.

· Preparing addendum of clinical over view for re-registration procedures.

· Preparation of SOPs and Pharmacovigilance master file.

· Giving Training for sales and non sales team about pharmacovigilance and collecting ICSRs.

July 2015-January 2016: Regulatory affairs specialist at Gulf Rider Company

(Dubai - UAE)

Job description:

- Preparing files for Registration, Renewal, and minor change variations for imported Veterinary vaccines, Human and veterinary food supplements and medicines.

- Support for document management by following up for the missing documents from the Manufacturers and making the Files ready for submission.

- Support for artwork checking to comply MOH or MOEW regulations.

- Support for product’s documents compliance with the MOEW and MOH regulations.

- Submitting files to MOH and MOEW along with doing online registration for Veterinary Vaccines (committee approval) and listing of other products.

March 2014 to June 2015: Pharmacist in charge (Bin Moosa medical pharmacy, khorfakkan, UAE)

July 2008 to November 2010: Pharmacist (Wally pharmacy, Dokki, Egypt) Job Description:

- Accurately dispensing drugs to patients according to a doctor’s prescription.

- Instructing patients on how to use medications, possible side effects and storage.

- Managing and resolving complaints.

- Talking to regular patients to see how their treatment is going.

- Able to trains and supervise Pharmacy Assistant.

- Giving private consultations when required.

- Maintaining pharmaceutical stock, creating inventories and ordering more drugs.

Spring 2013 & Fall 2012: Teaching assistant (Ajman University, Fujurah, UAE)

- Biochemistry for faculty of pharmacy and Dentistry,

- Organic chemistry, Medicinal chemistry for faculty of pharmacy.

- General Chemistry for faculty of dentistry.

October 2008 to January 2011:Teaching assistant, Faculty of pharmacy MSA University

(Modern Sciences and Arts), Egypt - Organic Chemistry Department. Job description:

- Teaching and assisting in the delivery of academic courses for undergraduates.

- Conducting practical courses in laboratories, supervising the lab and mentoring the students.

- Aiding students during extra office hours in the theoretical courses.

- Developing course materials including assignments, quizzes, practical courses’ handouts andPresentation.

- Co-supervising graduation projects of senior students.

- Course coordinator between professors and students in the department’s modules.

- Academic Advisor, helping with students’ registration process Career and Courses related Training

Attended the Pharmacovigilance Audit Training 2020 - Cairo - Egypt - February 2020.

Attended the Advanced Pharmacovigilance training hands on practice - Cairo - Egypt- 17/18 October 2018.

Attended the work shop of Essentials of Pharmacovigilance practice at faculty of pharmacy - Cairo university - May 2018

CTD file format training (Syndicate of Medical Toll Manufacturers) -2017

Attending the QPPVs Pharmaceutical Vigilance Training Organized by the Regional Pharmaceutical Vigilance Center in Cairo (EPVC-Cairo) - 2016

Introduction to Pharmacovigilance and ICSRs Handling training at Alandalous medical company - 2016

Pharmacovigilance SOPs Training at Alandalous medical company -2016

Attended and participated in all 6 waves workshops organized by the Egyptian Pharmacovigilance Center MOH and Arab union of Manufacturers of Pharmaceutical Appliances the new Harmonized Arab guidelines for Pharmacovigilance: 1) Wave VI Pharmacoepidemiology. May-June. 2016

2) Wave V Signal management, additional monitoring, safety communication, Post authorization safety studies. May. 2016

3) Wave IV Risk management system. April. 2016

4) Wave III Periodic Safety Update Reporting. April. 2016 5) Wave II Reporting of adverse reaction of medicinal products .March-April. 2016 6) Wave I Pharmacovigilance master file, Pharmacovigilance inspections, Pharmacovigilance audit. Jan- March 2016

7) Medical Writing and case Narrative Training. June 2016

Attending The Fifth National Pharmacovigilance Conference "Excellence in Pharmacovigilance" - Dubai - UAE - September 2015.

Training at Wally pharmacy (Egypt) as pharmacist - 2006&2007.

Training at National Organization for Drug Control and Research (NODCAR) (Egypt) in quality control department - 2007.

Training at Vacsera (Egypt) in quality assurance department - 2006. Activities:

Clinical pharmacology and therapeutics course at Giza Pharmacists Syndicate.

Shape your future course at the Egyptian Pharmacist Syndicate.

Participated the first student pharmaceutical conference (community and public health work shop) at faculty of pharmacy, Ain Shams University.

Participated the first pharmaceutical conference at faculty of pharmacy, Cairo University.

Attended communication skills sessions at the American university in Cairo (AUC).

Member in charity family at my college.

Computer Skills:

Windows :Excellent

MS Office :Excellent

Internet Use: Excellent

Personal skills:

Motivated

Hard Worker

Self-Confidant

Patient

Good Communication Skills

Presentation Skills

Languages:

Arabic : Mother tongue

English: Excellent

Personal Data:

Date Of Birth : 1-12-1985

Nationality : Egyptian

Religion: Muslim

Marital status: Married

Own Car : Not available

Driving License: Currently available (Egyptian and Emirates license). References:

Furnished Up on Request

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