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.