Drug Safety Associate
Resume:
Aamena Chaudhry
Somerset, New Jersey.
Mobile: 732-***-****
Email: ab179c@r.postjobfree.com
Qualification Summary:
Experience in creating case and entering relevant case information into the global pharmacovigilance databases (ARGUS, ARISg, Oracle AERS) to store and track all reported adverse event information.
Drug safety databases maintenance with exclusion of non-valid cases
Experience in collecting, investigating, evaluating, and processing clinical trial adverse events and spontaneous/solicited adverse events for post-marketed products.
Comprehensive knowledge over pharmacovigilance guidelines, ICH, GCP and FDA regulations.
Sound knowledge in coding medical terms using standardized medical dictionaries (MedDRA) and drugs using WHO Drug Dictionary.
Worked on ARGUS Oracle SQL/PL Drug safety domain
Implementation/conducting webinars/live classroom sessions on Argus office enterprise
(Drug Domain) for CRO/independent CRAs’
Documentation and follow up of/with CRO ARGUS safety training modules
Received and tracked information regarding potential adverse events submitted by all reporters including consumers, healthcare professionals, co-manufacturers, call centers, medical information centers, quality assurance and other company representatives accurately with in defined reporting timelines.
Processed serious adverse event information per sponsor’s standard operating procedures.
Attended internal meetings and summarize weekly documentation for studies.
Used to identify adverse events, seriousness, and listedness/labeledness for case completion.
Prepared clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulated follow-up information as per requests.
Experience in generating necessary queries by means of telephone calls, letters, electronic mails, and faxes to the consumer, physicians, other healthcare professionals, affiliates, and co-marketers in order to complete missing information essential to the case.
Assisted in generating periodic safety update reports (PSUR) and IND annual reports (generating index consisting of a line listing of all non-expedited reports for interval).
Professional Experience:
Drug Safety Associate Jun2011 - Present
Wyeth Consumer Healthcare Inc, Madison, NJ
Submitted ICSR’s to the regulatory authorities in a timely manner.
Processed serious adverse event (SAE) and non-serious adverse event reports, both individual and aggregated reports from post marketing and clinical studies.
Accurately entered data from source documents/ call center reports/ medical reports and proofread for completeness, accuracy and consistency of information.
Performed medical coding using MedDRA and WHO drug/CDD.
Drafted individual case summary reports and wrote concise case specific narratives as per company/product conventions.
Collected outcomes (AE’s, Interim variables and endpoints) to maintain the study objectives.
Prepared safety reports (case report tabulations) for new drug application.
Assisted in consolidating IND annual safety reports and periodic safety update reports.
Processed serious adverse event information per sponsor’s standard operating procedures.
Attended internal meetings and summarize weekly documentation for studies.
Used to identify adverse events, seriousness, and listedness/labeledness for case completion.
Prepared clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulated follow-up information as per requests.
Participated in weekly team meetings and departmental meeting about new conventions, products, reconciliation, labeling, regulatory relevant, manufacturing quality assurance information and product quality complaints.
Drug Safety Associate Jul 2008- Jun 2011
Pharmnet/i3 solutions, Princeton, NJ
Experience in creating case and entering relevant case information into the global pharmacovigilance databases (ARGUS, ARISg) to store and track all reported adverse event information.
Drug safety databases maintenance with exclusion of non-valid cases
Performed triage of potential adverse reports and search of duplicate cases.
Select event terms using clinical judgment and assess expectedness/ listedness of AE and SAE for company products.
Worked as drug safety associate in pharmacovigilance department in processing of the serious adverse reaction(s) / adverse reactions of marketed drugs need to be processed and report to manufacturing company as well as regulatory authority
Worked on ARGUS Oracle SQL/PL drug safety domain
Participated in weekly team meetings and departmental meeting about new conventions, products, reconciliation, labeling, regulatory relevant, manufacturing quality assurance information and product quality complaints.
May 2006 – June 2008 Research Associate, Research and Development, Lentigen, Maryland, USA
•
• Duties included using lentivector gene delivery technology for applications in biotechnology and
• medicine. Responsible for cloning, Polymerase Chain Reactions (PCR) on DNA using gateway technology,and infusion technology. Plasmid DNA isolation, transformation into E.coli XL 10 GoldCompetent Cells. Created vector backbones for particular plasmid constructs. Prepared solutions and preps. Use of HPLC technique to purify substances. Drug dissolution testing.
• Kept the laboratory clean and maintained a safe environment. Wrote and reviewed Standard Operating Procedures for laboratory instruments. Updated laboratory notebook regularly.
Education:
University of Maryland, Baltimore County Fall 2004-Spring 2007
Bachelor of Science: Biology
OTHER EXPERIENCE:
May-August 2004 Intern, Cardiac Care, Annapolis, Maryland
Sept. 2004-May 2005 Volunteer, of Maryland Medical Systems, R. Adams Cowley Shock Trauma Center
Sept. 2005-March 2006 Volunteer, University of Maryland Medical Center, Child Life
CERTIFICATIONS:
2010 DIA Phamacovigilance certificate
2009 CCRP-Certified Clinical Research Professional -SOCRA
Skills
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• ORACLE ARGUS Safety platform, ARGUS console configuration, ARGUS Security & Data Model
• Excellent Written and verbal communication skills; interpersonal skills
• Working understanding of documentation requirements in a regulated environment
• Demonstrated Good Documentation Practices
REFERENCES: Available on request.
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