Pharmacist, drug safety / pharmacovigilance, medical information
Resume:
Samer N. Ibrahim
Parlin, New Jersey 08859
***********@*****.***
pharmacovigilance/drug safety Specialist
I am a licensed pharmacist (Doctor of Pharmacy) with 2 years of industry experience in US and
Global Pharmacovigilance. I am a reliable, determined, and eager individual, who has experience in
many aspects of pharmacovigilance, including submissions of expedited reports to the FDA. I have a
solid grasp of the entire PV workflow, including processing of E2B, clinical trial, spontaneous, and
solicited cases. I am proficient at MedDRA and WHO coding, labeling assessment, narrative writing,
and other aspects of data entry.
objective
To follow exciting traditional and non traditional paths for pharmacists,
while honing in on the skills most critical to professional success and
personal development
Education
Doctor of Pharmacy,cum laude, 2012
Arnold & Marie Schwartz College of Pharmacy and Health Sciences
Long Island University, Brooklyn, New York
Cumulative GPA: 3.54/4.0
Honors Program, 2012
Long Island University, Brooklyn, New York
Business Minor, 2008
Long Island University, Brooklyn, New York
LICENSURES &CERTIFICATIONS
New Jersey Pharmacy License 12/06/2012 Present
Number: 28RI03542000
Work experience
6/10/2013 – Present Parsipanny, New Jersey
Global Drug Safety Specialist
LEO Pharma
• Using the pharmacovigilance system, ARISg, to perform single case
handling of AE/OE reports from HCPs, Health Authorities,
scientific literature, clinical trials, and consumers
• Responsible for prioritizing adverse event/other experience cases
and for the triage of cases based on case seriousness
• Checking for readability, correctness, and completeness of the
source documents, while following up with local affiliates and
authors of scientific literature for the 4 minimum criteria
• Performing MedDRA coding of cases for patient medical history,
laboratory test names, and events
• Using the WHO Drug Dictionary for coding of co suspected and
concomitant medications
• Performing the writing of case narratives for clinical trial cases,
literature cases, and serious/non serious cases
• Establishing listedness and causality assessments of both serious and
non serious individual case safety reports
• Ensuring case quality, by running weekly quality control reports.
• Keeping case compliance, by ensuring that reporting timelines are
met, and creating deviations when applicable
• Contribute to the creation and maintenance of department SOPs,
work instructions, and work tools, while participating in meetings as
required
Project related tasks
• Coordinator of the QC review task team
• Assure consistency for all cases according to the working
instructions and feedback from the European Medicines Agency
(EMA)
• Performing case overview reports for upcoming aggregate reports,
specifically the PADER
• Follow up optimization project
• Assist in exploring and implementing the follow up capabilities
within ARISg, in order to allow for a more efficient case entry
process.
Validation testing within ARISg
In sourcing Project
Updating user requirement specifications for the insourcing of a major
company product
• Product responsible person for psoriasis related medications and
clinical trials within the US hub
Ensuring that deadlines are met for product data lock points
Overseeing clinical trials from start up to completion for PV related
matters, such updating ARISg with study related information,
participating in clinical trial meetings, keeping track of follow up
queries
5/17/2012 – 6/9/2013 Parsipanny, New Jersey
Drug Safety Specialist
LEO Pharma Inc.
Responsibility split between pharmacovigilance and medical information
Involved in the intake, documentation, and follow up of adverse
events/other experience cases
Responsible for expedited case submission of adverse event cases and
other event cases to the FDA
1. Review the cases for completeness and determine whether or not
the cases should be submitted to the FDA based on the US
labeling, seriousness of the case, and causality
Reviewed PADERs from HQ for listings of 15 day alert reports, listings
of non 15 day reports, and FDA 3500A forms for all non 15 day reports
Assisted with local journal review to identify adverse event reports
Ensured case compliance by respecting deadlines
Performed case reconciliation with global database
Answered medical inquiries from Health Care professionals, track
medical inquires in the database, assist with the development of standard
response letters, and provide training on company specific products
Participated in department meetings and contribute to the maintenance
of department SOPs, work instructions, and work tools
Attended 2012 DIA Post marketing Drug Safety and Pharmacovigilance
conference in Boston, MA
Provided pharmacovigilance training to entire US affiliate and
participated in medical conversation at the 2013 American Academy of
Dermatology (AAD) Conference in Miami, FL
Received the Drug Information Association’s (DIA) training on how to
prepare for a FDA inspection
Participated in company PV audit and directly involved in the affiliate’s
first FDA inspection
Industry Clerkship Experience
2/23/2012 – 3/9/2012 Brooklyn, New York
International Drug Information Center
Received and responded to external inquiries from subscribed healthcare
providers using a systematic approach that allowed for legal, ethical, and
timely responses
9/9/2011 – 10/10/2011 Montville, New Jersey
Bayer Health Care Pharmaceuticals: Pharmacovigilance
Assisted in the finalization of Drug Safety follow up letters, started the
process for the development of a company dashboard for KPI’s, and
received ARGUS software training
Contact this candidate