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Maryam Kotb, pharmacovigilance associate

Maryam Kotb

pharmacovigilance associate·Sanofi

Canada

Master's degree, Business Administration

Work experience

Total years of experience: 19 years, 4 months

pharmacovigilance associate

November 2019 - Present

Sanofi

Laval, Canada

November 2019 - Present

▪ Data Entry of ICSRs (initial, follow-up, serious, non-serious, solicited, non-solicited, drug, medical device) to GPV (Global
Pharmacovigilance) or licensed partners as per corporate and local requirements and timelines.
▪ Processing CIOMS reports received from partners for domestic and international cases in preparation for evaluations by PV specialists.
Following evaluations by PV specialists, processing reports for submitting to Health Canada.
▪ Ensuring that all ICSRs for drugs and medical devices subject to expedited reporting according to Canadian regulations are submitted to
Health Canada within prescribed timelines.
▪ Preparing written follow-up requests for ICSRs as per corporate and local requirements.
▪ Documenting all activities related to Canadian ICSRs and international reportable ICSRs.
▪ Processing medical device ICSRs and PTCs (Product Technical Complaints) as per local and corporate requirements, including ICSRs
from the Diabetes Call Centre. Maintaining paper and electronic filing of such activities, including data entry in the local PV tracking
database.
▪ Performing reconciliations and quality checks of PSP programs as per corporate requirements.
▪ Submission of reports to regulatory authorities
▪ Maintaining paper files for all PV activities as per Canadian and corporate requirements and according to GDP (Good Documentation
Practices).
▪ Maintaining an accurate and efficient electronic filing system for all PV activities to ensure efficient functioning of the team.
▪ Participating in the administration of the PV tracking database (Remedy) including modifications, corrections, and adjustments for
continuous improvement of the system.
▪ Participating in the development of quality documents describing the technical steps of coordinator activities.
▪ Providing overall support to the PV team, including the PV Head and PV specialists, on all team activities.

Company industry:
Pharmaceutical Manufacturing
Job role:
Medical, Healthcare, and Nursing

Pharmacy Assistant

July 2019 - November 2019

PharmaPrix

Joliette, Canada

July 2019 - November 2019

- Gathering and entering patient information and doctors' prescriptions in computer systems.
- Assessing prescriptions for completeness.
- Preparing and packaging prescription medications.
- Compounding non-sterile pharmaceutical products.
- Maintaining prescription and inventory recordkeeping systems,
- Maintaining proper drug storage and security.
- Placing and receiving orders for stock to maintain inventory.

Company industry:
Pharmacies
Job role:
Medical, Healthcare, and Nursing

A full-time student in PROGRAMME FRANCISATION MIDI

August 2018 - June 2019

École Barthélemy

Joliette, Canada

August 2018 - June 2019

A full-time student in the French language course offered by Quebec Ministry of Immigration Diversity and Inclusion, École
Barthélemy (Aug. 2018-Jun. 2019), Joliette, QC, Canada

Company industry:
Training & Education Center
Job role:
Teaching and Academics

Community Pharmacist

February 2014 - February 2018

Garden City Community Pharmacy

Cairo, Egypt

February 2014 - February 2018

- Community Pharmacist (Feb. 2014- Jan. 2015)
- Senior Pharmacist (Feb. 2015- Jan. 2016)
- Shift Leader (Feb. 2016- Feb. 2018)

▪ Dispensing prescriptions and over-the-counter medicines and formulations.
▪ Giving advice on how medicines work.
▪ Ensuring that all Health & Safety requirements are met, and that all necessary records are kept/maintained.
▪ Ensuring that the range and level of stock is maintained to a level that meets the needs of the business.
▪ Supervising and coordinating the activities of other pharmacists, pharmacy assistants, pharmacy technicians and other staff.

Company industry:
Pharmacies
Job role:
Medical, Healthcare, and Nursing

Associate Lecturer

September 2006 - January 2014

Modern University For Technology And Information

Cairo, Egypt

September 2006 - January 2014

- Associate Lecturer (Oct. 2011- Jan. 2014)
- Teaching Assistant (Sept. 2006- Sept. 2011)

Job Responsibilities:
▪ Teaching Tasks
Teaching Basic Microbiology, Immunology, Parasitology & Pathology, and Medical Microbiology from September 2006 to January 2014,
being responsible for preparing the practical sessions' presentations, facilitating discussion sections or tutorials; holding weekly office hours;
grading homework, assignments, practical exams, and projects; keeping records; distributing and copying reading materials; and preparing
answer keys or supplementary notes.
▪ Extra Co-academic & Curricular Activities:
 Academic coordinator being responsible for:
- Developing the different timetables of the faculty.
- Ensuring that the courses are offered according to the study plan.
- Selecting the best convenient timings for the faculty required courses that suit the majority of the students' schedules.
- Coordinating with other faculties at the University which offer courses for the Pharmacy students to ensure that such courses are offered
in convenient times.
- Assigning suitable rooms / labs for courses.
- Checking for the need for courses required for graduating students and proposing the suitable suggestions.
- Ensuring that the timetable is approved by the dean, and that all faculty members are informed about what, when and where they will
teach.
 An active member of:
- The Quality Assurance Unit of Faculty of Pharmacy, M.T.I.
- Abroad Universities-MTI validation unit.

Company industry:
Higher Education
Job role:
Teaching and Academics

Education

University Of The People

April 2020

April 2020

Master's degree, Business Administration

United States

Beni-suef University

October 2011

October 2011

Master's degree, Microbiology

Egypt

Misr University For Science And Technology

August 2006

August 2006

Bachelor's degree, Pharmacy

Egypt

Languages

Arabic

Native Speaker

English

Expert

French

Intermediate