1. Michele Ahmad
397 Goffle Road, Ridgewood New Jersey (201) 925-7282 Email mbahmad01@gmail.com
Skills
Self-motivated professional with over two years of experience in the pharmaceutical industry specializingin drug
safety. Proficientin MicrosoftWord,Excel, PowerPoint, Outlook, Adobe Acrobat, Argus, Medra, WHO drug
dictionary,SharePointand IRT.
Education
William Paterson University- Wayne, New Jersey
Bachelor of Science in Biology May 2009
Experience
Drug Safety Coordinator (Contractor) October 2014 to Present
Shionogi In. Florham Park, NJ
 Responsiblefor managingthe spontaneous and clinical adverseevent mailbox for casesafety reports
(ICSR).
 Responsiblefor identifyingadverseevents and processingeach report in accordancewith regulations and
guidelines.
 Responsiblefor triagingreports.
 Initial receiptand preliminary data entry of adverse event casereports into Argus.
 Sending out confirmation receipts for ICSR reports.
 Practicinggood documentation, keeping all sourcedocuments in files.
 Responsiblefor action items, sendingout queries to clinical sites and generatingfollowup letters.
 Caseprocessingserious and non-seriouspostmarketingreports and clinical trial reports.
 Monthly and weekly reconciliation with licensed partners.
 Ensure timely preparation & submission of reports to regulatory agencies in accordancewith applicable
regulations
 Submission to the FDA of Study and Post-Marketing adverse event reports received from clinical sites,Call
Center or Medical information per SOPs and Study Protocols.
 Review individual safety reports and assesses validity for submission to licensepartners based on
exchange criteria in licensepartner agreements
 Review and exchange non-assessed reports to licensepartner as per Pharmacoviligenceagreements.
Pharmacovigilance Associate (Contractor) April 2014 to August 2015
Ferring Pharmaceutical. Parsippany, New Jersey
 Responsiblefor managingthe US and Global mailbox for casesafety reports (ICSR).
 Initial receiptand preliminary data entry of adverse event casereports.
 Initial adverseevents casereport completeness review.
 Identification of productquality reports
 Process due diligencereports
 Interact with internal departments to resolvequestions.
 Reviewed, ranked, verified, processed and documented case-related information:event terms; report
validity,event seriousness criteria,accuracy and consistency,within regulatory timelines.
 Facilitated accuratedata entry of individual casesafety reports (ICSR) into adverse event data base.
 Wrote and edited casenarratives for Individual CaseSafety Reports (ICSR).
 Involved in editing General Standard Operational Procedures (SOPs) to meet FDA requirements.
 Performed weekly and monthly Reconciliation reports.

2.  Proficientin codingthrough MedDRA and WHO Drug dictionaries.
 Demonstrate knowledge of and compliancewith established document management processes,guides,
policies,and SOPs.
 Undertake additional assignments on an as-need basis.
Drug Safety Associate (Contractor) July, 2013 to Jan, 2014
Johnson & Johnson-Morris Plains, New Jersey
Global Medical Safety, PV Operations, Division of Johnson &Johnson Pharmaceutical Research &
Development, LLC
 Facilitated accuratedata entry of individual casesafety reports (ICSR) into adverse event data base.
 Prepared a clear and conciseclinical narrativewhen indicated and independently assigned MedDra coding
to adverseevents with accuracy.
 Performed duplicatesearchingto maintain consistency with the global adverseevent data baseand alert
senior managers to unusual numbers of similar reports.
 Identified clinically significantinformation fromfollow-up reports and updated missinginformation in the
initial ICSR.
 Obtained casereceipt for all adverseevent information from LSO and licensingpartners to maintain
compliance.
 Implemented and understand GMS systems, FDA regulations and SOP procedures when processingall of
the company’s pharmaceutical products and medical devices.
 Achieved data entry goals and demonstrated the ability to work under pressureto meet compliance.
 Involved in adverse event databaseupgrades,casemanagement team meetings and projects with
direction.
 Demonstrate knowledge of and compliancewith established document management processes,guides,
policies,and SOPs.
 Other duties as assigned.
Drug Safety Associate (Contractor) October, 2010 to November, 2012
Pfizer, Bridgewater, New Jersey
 Performed Individual CaseSafety Reports (ICSR) processingactivities,wrote and edited casenarratives in
Argus
 Reviewed, ranked, verified, processed and documented case-related information:event terms; report
validity,event seriousness criteria,accuracy and consistency,within regulatory timelines.
 Developed and maintained expertise and knowledge for applicablecorporateand global regulations,
guidelines,Standard OperatingProcedures,data entry conventions,and search functions in the safety
database.
 Provided codingexpertise for legacy King cases (Beingmigrated into Argus) in addition to quality review.
 Prioritized workload whilesimultaneously workingwith Wyeth migration,King,Janssen,CIOMS, Enbrel
and Aurobindo sourcedocuments.
 Mentored contractors on data entry procedures for unmapped sourcedocuments from LP-Janssen AI for
product: Bapineuzumab in addition to Wyeth migration and CIOMS sourcedocuments.
 Responsiblefor the quality review of Wyeth migration data entry and notifyingrequestors of case
completion.
 Interacted with the Therapeutic Area Teams, Quality Safety Alliances,and other functional groups to
ensure adherence to processes and procedures.
 Proficientin codingthrough MedDRA and WHO Drug dictionaries.
 Demonstrate knowledge of and compliancewith established document management processes,guides,
policies,and SOPs.

3. Research and Analytical Experience August 2007 to May 2008
Clinical Laboratory- William Paterson University
 Focused on autistic BTBRstrain micein order to demonstrate inversebehavior when induced to
methamphetamines for research purpose
 Biochemical tools were employed usingintraparanatal injectionsto run behavioral trial studies.
 Experimental techniques includegene cloning,genomic DNA preparation,Gel electrophoresis,plasmid
DNA preparation,total RNA preparation,cell culture,and spectrophotmetry technique.
 Explored new insightinto the mechanismof gene regulation and inversebehavior.
 Formulated experimental design, data interpretation, creativethought processes,preparation and writing
of manuscripts as well as formal and informal presentations were devoted to experimental design.
References upon request