Hi, I’m
AMIRA OMER
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy with more than 10 years of rich experience and successful track records in the pharmaceutical field .
Overview
21
years of professional experience
7
Certification
Work History
AL Maahi Drug store
Pharmacist-in-Charge -regulatory Affairs Officer
01.2023 - Current
ALPHA GROUP OF PHARMACIES
Learning and Development Manager
01.2022 - 08.2022
Job overview
- Collected information about company objectives and employee deficiencies in order to assess training needs.
- Developed engaging and entertaining presentations to maintain employee attention and improve impact of training.
- Improved organizational efficiency and control costs by educating 20 employees on resource and time management.
- Reviewed effectiveness of programs and proposed updates to maximize success.
PDC – UAE Sharjah Site/Abu Dhabi (ADNEC) Sites
Clinical Researcher -pharmacovigilance Specialist
08.2020 - 08.2021
Job overview
- Monitoring phase Ⅲ clinical study of inactivated SARS-COV-2 vaccines (Vero cell) Developed by Sino Pharm CNBG, sponsored by G42
- The study recruited various numbers of volunteers for instance 31000 volunteers in UAE, 6000 in Bahrain, 6000 in Egypt and 500 in Jordan
- Main activities/responsibilities: Overseeing the smooth running of clinical trial
- Provide training to the doctors and the research coordinators on site (protocol amendments, SAE, proper documentation, ICF, diaries review, technical procedures, etc.) Collection and preparation of regulatory documents for study submission and approvals in addition to any amendments and ongoing study updates
- Reporting Safety cases adverse events /SAEs initial reports to the EC (AE/SAE) SDV and modified summary reports preparation for submission to the EC
- Provision of logistic support in SDV, preparation of Protocol deviation reports for submission to the EC, review (ICFs, Diaries), preparing trackers/reports to be ready for the Audits, preparing ICF subject level review tracker and monitoring visits reports
- Monitoring documentation, QC all supporting reports (laboratory reports /SI SDV) to ensure that they are reviewed by the physician within appropriate timelines and flag any out of range values
- Preparation, maintenance, archiving of ISF, laboratory, Safety files as per GCP/GDP guidelines and sponsor/ company SOP requirements, including correct completion and modification of project-specific templates
- Input all data in the CRF/data collection tool from the source data /notes and track the flow of CRFs, solving queries and reporting out the flow data Identifying quality issues (QI) reporting them and applies CAPA reporting and root case analysis
- Accountability, fridge temperature monitoring, monitor the vaccine count daily (in and out), preparing daily work log
- Monitoring study activities/ research participants to ensure compliance with protocols along with the rules and regulations of ICH-GCP, other regulatory, ethical guidelines and data protection regulations
- Ensure that protocol visit windows are scheduled according to the protocol requirements and report deviations
- Assist site for in subjects' recruitment, retention and completion of Case Report Forms (CRF) paper and e-CRFs
- Track enrollment status of subjects and document dropout information (ICFs and Diaries)
- Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress, outcomes to be expected and understanding their concerns
- Direct the collection, labeling, storage, and shipment of specimens Liaising with laboratories or investigations regarding laboratory findings
- Directing Laboratory findings corrective actions
- Attending all the training and meetings related to the study.
Prime care pharmacy
Pharmacist-in-Charge
09.2016 - 11.2018
Job overview
- Evaluated patient histories to assess medication compliance and spot issues such as doctor shopping or excessive usage.
- Recommended OTC devices or medication options to help mitigate individual symptoms.
- Developed policies and procedures for effective pharmacy management and business development
- Ordered all pharmacy supplies and kept check on inventory levels.
- Protected drug inventories from damage or theft by establishing and enforcing clear pharmacy security policies.
- Trained pharmacy interns and newly hired pharmacy technicians.
- Monitored and managed pharmacy staff performance to maximize productivity and customer satisfaction.
- Monitor controlled/semi-controlled drugs and reporting to the MOH monthly-insurance policies
Manchester Community pharmacy (CHS GROUP)
Pharmacist-in-Charge
09.2013 - 12.2015
The Palm Pharmacy (MARINA GROUP)
Pharmacist-in-Charge
09.2009 - 08.2013
ADCO Pharmaceutical Company
Quality Control Analyst
01.2004 - 09.2009
Job overview
- Chemical and microbiological analysis of all the company products throughout the production phases and submission of results reports for proper actions to ensure the highest quality standards.
Group Pharmacies
Pharmacy Manager
10.2002 - 09.2009
Job overview
- DR/AHMED SHAWER pharmacy Cairo, Egypt
- DR/MOHAMED FAROUK pharmacy Cairo, Egypt,
- THE MERELAND HOSPITAL pharmacy Cairo, Egypt (Big pharmacy inpatient and outpatient) (2002-2004)
Education
Ain Shams University , Cairo, Egypt.
B.Sc. from Pharmaceutical Science (clinical Pharmacy)
08.2002
University Overview
- 4 GPA
Skills
- Strong scientific background
- Quick learning ability and Can-do attitude
- Analytical mindset detailed oriented
- Problem solving abilities
- Project management ,business development
- excellent selling , strong negotiation and communication skills
- professional corporate trainer
Languages
Arabic
Arabic
Arabic
Interests
Traveling, swimming, diving, sports, and music listening
Personal Information
- Nationality: Egyptian
- Driving License: UAE Driving License
References
Available on request
Certification
- Medical director (DHA) license (February 2010) Dubai Health Regulation Authority dubai, UAE
- Pharmacist (MOH) license (July2007- revaluated July 2019) Ministry of health ,UAE
- Pharmacovigilance and Drug safety -Comply with European & US law - Certificate. (June 2021) Accredited by the Faculty of Pharmaceutical Medicine of the Royal college of Physicians of the United Kingdom
- Good clinical practice (GCP) certified (September 2020) NIDA Clinical Trial Network.
- • TOT-Certified (February 2020) American East Coast University USA/KHADA attested
- Regulatory Affairs Essentials for Human Medicinal Products – EU and US Certificate (July 2018) Accredited by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom
- ACRP CRA Certification (ongoing)
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Pharmacist-in-Charge -regulatory Affairs Officer
AL Maahi Drug store
01.2023 - Current
Learning and Development Manager
ALPHA GROUP OF PHARMACIES
01.2022 - 08.2022
Clinical Researcher -pharmacovigilance Specialist
PDC – UAE Sharjah Site/Abu Dhabi (ADNEC) Sites
08.2020 - 08.2021
Pharmacist-in-Charge
Prime care pharmacy
09.2016 - 11.2018
Pharmacist-in-Charge
Manchester Community pharmacy (CHS GROUP)
09.2013 - 12.2015
Pharmacist-in-Charge
The Palm Pharmacy (MARINA GROUP)
09.2009 - 08.2013
Quality Control Analyst
ADCO Pharmaceutical Company
01.2004 - 09.2009
Pharmacy Manager
Group Pharmacies
10.2002 - 09.2009
Ain Shams University
B.Sc. from Pharmaceutical Science (clinical Pharmacy)
- Medical director (DHA) license (February 2010) Dubai Health Regulation Authority dubai, UAE
- Pharmacist (MOH) license (July2007- revaluated July 2019) Ministry of health ,UAE
- Pharmacovigilance and Drug safety -Comply with European & US law - Certificate. (June 2021) Accredited by the Faculty of Pharmaceutical Medicine of the Royal college of Physicians of the United Kingdom
- Good clinical practice (GCP) certified (September 2020) NIDA Clinical Trial Network. • TOT-Certified (February 2020) American East Coast University USA/KHADA attested
- Regulatory Affairs Essentials for Human Medicinal Products – EU and US Certificate (July 2018) Accredited by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom
- ACRP CRA Certification (ongoing)
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