Adel G. Said is seeking a position as a drug safety and pharmacovigilance associate. He has over 7 years of experience in the pharmaceutical industry, including roles in pharmacovigilance and drug safety at Servier Pharmaceuticals in Egypt. He has a Bachelor's degree in Pharmaceutical Sciences from Alexandria University in Egypt and is currently interning at Rite Aid pharmacy in Princeton, NJ. His experience includes adverse event reporting, drug coding, clinical trial monitoring, and ensuring safety guidelines are followed.
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An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
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This document is expressing the carrier opportunities in clinical research and how it important to learn clinical research for our society and the best institute providing absolute best training for the clinical research
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If you are a BSc/MSc/PhD or MD/PharmD in career change, you can see some of the available career opportunities in the Clinical research industry and how to get in this field in this presentation made on Jan 14, 2017 at the Pharmacolloque 2017:
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There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
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Identify Compound Development Strategies to Optimize Success in Clinical Trials
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If you are a BSc/MSc/PhD or MD/PharmD in career change, you can see some of the available career opportunities in the Clinical research industry and how to get in this field in this presentation made on Jan 14, 2017 at the Pharmacolloque 2017:
https://cra-school.com/news/
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What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
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Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages
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There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
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Identify Compound Development Strategies to Optimize Success in Clinical Trials
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Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
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Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
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Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Career Opportunities in the Clinical Research IndustryAccess-Pharma Jobs
Career Opportunites in Clinical Research, Regulatory Affairs, and Pharmacovigilance. International Clinical Research Academy and Access Clinical Research
1. Adel G. Said
16 Red Oak Row
Princeton,NJ. 08540
609-233-7874
adel_guirgis@yahoo.com
PROFESSIONAL OBJECTIVE: To work as a drug safety and Pharmacovigilance associate
responsible for the administration and maintenance of the adverse event and drug dictionaries
within the Global Medical Safety. and examine drug trials closely for safety, maintain records of
experiments, perform research, and establish safety guidelines.
Professional Summary:
Provides integrated strategic safety expertise to clinical development programs. Performs
active pharmacovigilance with rapid identification and analysis of safety signals, to define
emerging drug safety profiles of all products and drive patient risk management. Delivers high-
quality product safety data and analysis to internal and external customers throughout the
product life cycle.
Education:
Bachelor degree in Pharmaceutical sciences from Alexandria University Egypt 2004. With
equivalent degree from National Association of Boards of Pharmacy.
Core Competencies:
Seven years of progressive experience in pharmaceutical industry
Comprehensive knowledge of medical writing and analyzing complex medical data
Good communication and interpersonal skills
Ability to succeed in a fast and commercial working environment
Knowledge of e-learning and publication development
Strong organizational, motivational and organizational skills
Flexible and willing to travel internationally
Ability to work as a part of a team and independently
Ability to guide and convince client as well as colleagues in therapeutically areas.
Skill Highlights:
Comprehensive knowledge of international drug safety and pharmacovigilance principles and
regulations.
ARGUS experience, Accept E2B cases received through the Argus Electronic Submissions
Module (ESM)
Data entry/case receipt/Book-in/quality check/E2B.
MedDRA coding dictionary.
ARGUS, Outlook, Excel and PowerPoint .
Familiarity with the research process for drug trials.
In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements,
technical requirements, and guidelines.
Skilled in technical and general communication, both in wiring and verbally
Strong knowledge of quality management procedures and compliance monitoring.
Good leadership, analytical, problem-solving and time management skills.
Professional Experience:
pharmacy intern at Rite Aid pharmacy at Princeton NJ from 12/2014 till now.
o Recoding of adverse events and other safety data (medical history, disease states, and
indications)
o Completion of risk and quality (label, approval, manual coding and quality review steps).
o Upload AE reports to the Drop in Data Entry.
o Awareness of company procedures and guidelines to maintain regulatory compliance
o Quality oriented, with attention to detail/accuracy
o Patient counseling expert.
o Data entry experience .
o Strong clinical background.
o Problem solving skills.
o Ability to follow guidelines, working practices and policies.
2. Adel G. Said
16 Red Oak Row
Princeton,NJ. 08540
609-233-7874
adel_guirgis@yahoo.com
o Retail pharmacy procedure knowledge.
o Exceptional patient care and interaction.
o Great scientific background and complete medical knowledge.
o Managed daily duties in all pharmacy department.
o Excellent Patients counseling skills and skilled customers service.
o Ability to work as team with a very positive attitude and great enthusiasm.
Drug Safety Associate / Pharmacovigilance Specialist
SERVIER Pharmaceuticals Cairo,Egypt
December 2007-December 2014.
o Completion of full case information on the database, including quality review to ensure
accuracy and completeness..
o Ensure proper coding of events and drugs for cases to ensure correct forwarding to the
relevant Therapeutic Area Teams and Licensing Group.
o Monitor electronic mailboxes and ARGUS ESM to ensure timely acceptance of Adverse Event
(AE)
o Accept E2B cases received through the Argus Electronic Submissions Module (ESM) from
European Health Authorities.
o Coding of all clinical study AE and Medication data to facilitate meeting project timelines.
o Maintaining and supporting the development of clinical dictionaries and writing narratives used
in clinical data analysis.
o MedDRA coding dictionary and MedDRA Points to Consider.
o Discussion of source documents, coding conventions and ad-hoc queries with
Pharmacovigilance Physician.
o Assist in development and maintenance of Dictionary SOPs and Working Instructions.
o Fully participates in daily case processing activities and assist other associates with case and
workflow management. Participates in QC activities.
o Manages activities in specific projects as assigned. These projects may include but are not
limited to electronic submission, creating reports, periodic report processing and REMS
participation.
o Interfaces with other departments to facilitate information exchange and communicates
information to ensure clear and consistent reporting.
o Follow SOP's associated with processing of Clinical Grade Cellular Therapeutics.
o Create or update SOP/WI as required by manager.
o Triage and classify ICSRs for report type, seriousness, causality, expectedness/labeling and
reporting, prioritize ICSR according to regulatory requirements.
o Follow Company Safety, Health, and Environmental policies and procedures
o Performing research, and tracking of safety issues associated with drugs.
o Monitoring drug trials and ensuring all the safety protocols are followed.
o Organizing and analyzing research data for investigating side effects of drugs.
o Maintaining documents of all lab experiments and case reports.
o Providing information to general public and staff about drug safety.
o Researching on chemical components and determining their uses for clinical treatment.
o Assemble and review the product as well as suggest core product attributes.
o Performs review of the choice of comparators for the purpose of clinical trials Comprehensive
knowledge of international drug safety and pharmacovigilance principles and regulations.
o Familiarity with the research process for drug trials.
o In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements,
technical requirements, and guidelines.
o Strong knowledge of quality management procedures and compliance monitoring.
o Good leadership, analytical, problem-solving and time management skills.
3. Adel G. Said
16 Red Oak Row
Princeton,NJ. 08540
609-233-7874
adel_guirgis@yahoo.com
o Great scientific background and complete scientific knowledge in diabetes, cardiovascular and
anti-depressants line.
Pharmacy Manager
EL-Gawaher Pharmacy Alexandria, Egypt. July 2004 to December 2007.
Reference:
On request.