Samer N. Ibrahim

* ****** ******

Parlin, New Jersey 08859

917-***-****

acdxjv@r.postjobfree.com

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