Safety Quality Assurance
Resume:
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Chumnith Peter Bour
Stratford, CT 06614
acecgo@r.postjobfree.com
Objective
To gain the position within Pharmacovigilance in Drug Safety with knowledge in the field of pharmaceutical
sciences, by applying both knowledge and experience acquired from both studies and experience as a
Pharmacovigilance Associate.
Education
Massachusetts College of Pharmacy & Health Sciences Boston,
MA
B.S Pharmaceutical Sciences, Class of 2009
Relevant Experience
• EDC experience with Medidata RAVE and Inform databases
• Knowledge in FDA and Regulatory Affairs
• Operating to S.O.Ps, cGMP, ICH Guidelines, and WI requirements
• Reviewed and assessed all source documents, and compile data in Argus safety database
• Initial entry and reporting of AE and SAE in timely manner
• Performed triage for incoming initial and follow-up reports
• Coded events using MedDRA dictionary
• Coded products using the WHO drug dictionary
• Narrative writing for many different reports. (i.e., clinical trial, spontaneous, literature, regulatory, etc.)
• Reporting and Documenting Serious Adverse Events to relevant databases and agencies
• Reconciliation with Internal and External Affiliates
• Argus, Clintrace, Empirica Trace, Infolinx, and Citrix database trained and certified
• Cognos reports, line listings, and QC of cases
Professional Experience
Purdue Pharma L.P., Stamford, CT – Drug Safety and Pharmacovigilance
Senior Drug Safety Analyst – Drug Safety Operations Feb. 2013 –
Present
• Assess, process, and data enter all case types to meet compliance requirements
• Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional
incoming information to determine reportability
• Identify potential product complaints
• Perform all appropriate coding
• Own case narrative: accept or revise auto-narrative (template); create narrative text as required
• Complete initial and follow-up narratives
• Determine follow-up requirements and recommend follow-up type (phone call, letter, etc.); formulate
and generate queries
• Interact with internal and external groups on safety reports
• Work on highest priority or assigned cases using Workflow Management System; use daily Compliance
report
• Perform own QC of reports
• Perform reconciliation of clinical SAEs
• Contribute to production of periodic Safety Update reports (case and data clean-up)
Receive incoming Adverse Events and Product Complaints from any source and follow-up as
appropriate to obtain additional information needed for processing the case
• Assist with review of scientific literature articles when required
• Assist with advanced case processing activities (merging cases, deletion, distribution to other companies,
etc.)
• Assist in receiving and documenting incoming calls and performing follow-up (AE and PC)
• Assume project responsibility as assigned
Harvard Clinical Research Institute, Boston, MA – Cypress Trial, Tryton Trial, DAPT Trial
Clinical Safety Associate II – Case Processing and Management Jun. 2012 – Feb. 2013
• Triaging, collecting, monitoring, processing, and distributing the adverse event reports (serious and non-
serious Adverse Event(s) ) to sponsor or regulatory authorities and project team within specified
timelines
• Cardiovascular study specializing on drug and device clinical trial
• Generate queries related to serious and non-serious Adverse Event and follow up until resolution.
• Perform all safety database required functions, e.g. data entry, narrative preparation, dictionary
management etc, until completion of the case, and retrieve all customized and other regulatory reports.
• Perform 100% Case Report Form Review if specified by the Sponsor
• Perform comparative review of Clinical and Safety database and reconciliation of all adverse events.
• Coordinate with the assigned Clinical Reviewer for the adjudication of Mace and/or endpoint events that
require CEC adjudication.
• Prepare PSUR, DSUR, monthly reports, line listings, and reconciliation per SMP of clinical trial.
• Perform other safety-related tasks that may be required for specific protocol or due to change in
regulatory requirements.
• Follow moral and professional standard for conducting day to day activities.
• Responsible for triaging all reported Serious Adverse Event(s) and UADE reports from study site via
telephone or fax copies and document all required information in tracking log.
• Follow internal company Standard Operating Procedures for execution of tasks
Smith & Hanley Consulting, an Inventiv Health Company @ Harvard Clinical Research Institute, Boston,
MA - Contract
Clinical Safety Associate I – Case Processing and Management Dec. 2011 – Jun. 2012
• Triaging, collecting, monitoring, processing, and distributing the adverse event reports (serious and non-
serious Adverse Event(s) ) to sponsor or regulatory authorities and project team within specified
timelines
• Cardiovascular study specializing on drug and device clinical trial
• Generate queries related to serious and non-serious Adverse Event and follow up until resolution.
• Perform all safety database required functions, e.g. data entry, narrative preparation, dictionary
management etc, until completion of the case, and retrieve all customized and other regulatory reports.
• Perform 100% Case Report Form Review if specified by the Sponsor
• Perform comparative review of Clinical and Safety database and reconciliation of all adverse events.
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• Coordinate with the assigned Clinical Reviewer for the adjudication of Mace and/or endpoint events that
require CEC adjudication.
• Provide coverage for serious adverse events reported during non business hours, weekends, and holidays
on rotational basis, as required by assigned protocols.
• Perform other safety-related tasks that may be required for specific protocol or due to change in
regulatory requirements.
• Follow moral and professional standard for conducting day to day activities.
• Responsible for triaging all reported Serious Adverse Event(s) and UADE reports from study site via
telephone or fax copies and document all required information in tracking log.
• Follow internal company Standard Operating Procedures for execution of tasks
Genzyme Corporation, Cambridge, MA Dec. 2009 – Dec. 2011
Drug Safety Specialist – Case Processing and Management DEC. 2010-Dec.2011
• Assemble/update the electronic case folder based on the specific characteristics of the case (e.g. event,
reporter, medical assessment, reportability, country of origin, etc.).
• Complete data entry into safety database, verify coding, and complete narrative description of the
experience (including Clinical Development Input Form for clinical trials).
• Perform quality review for case entry
• Finalize follow-up queries, as necessary.
• Review and refine narrative, include source document review, verify Medical Coding Group coding, and
perform in process quality review for case review.
Advance serious and event of interest cases to medical review
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Identify cases to unblind when applicable
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Indentify clinical cases that require output for analysis of similar events
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Based on information provided by medical reviewer, make modifications as instructed (e.g. coding) and
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perform in-process quality review.
Generate and send a follow-up letter/queries to the appropriate reporter using the most expedient
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mechanism, forwarding to legal, and Quality Assurance, and/or Associated Business Partner where
appropriate.
Assist Surveillance Scientist in the preparation of aggregate reports as needed
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Conduct specific database searches and retrievals for drug-event information as needed.
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Participate in staff training sessions and external training sessions to remain current in therapeutic area
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regulations.
Assist QTC with creative solutions to corrective action/preventive action (CAPA) trends
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Document reasons for late cases.
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Drug Safety Associate – Intake and Reporting Dec. 2009 – DEC.2010
Accountable for the triage of all safety information received via e-mail, PDF, fax, telephone, internal
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and/or external mail.
Assign Manufacturers Control Number and enter preliminary adverse event data into safety and or QA
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data bases.
Assemble information, date stamp, image source documents, create paper and/or electronic folders,
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associate electronic/paper information to electronic/paper folder as appropriate
Verify the presence of all information required to be a case (product, reporter, event, and patient), and
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request critical missing information for non-cases by expeditiously contacting the reporter.
Identify duplicates and non-cases. Incorporate physician input, append case files and perform in-process
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quality review for case receipt.
Submit/provide MedWatch/CIOMS I/E2b reports as applicable. Update the safety database with the
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submission date.
Generate and work with other team members to send a follow-up letter/queries to the appropriate reporter
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using the most expedient mechanism, forwarding to clinical sites where appropriate.
Identify database cases eligible for archiving.
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Perform reconciliation with licensing partners and CROs to ensure compliance and accurate receipt of all
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adverse event information.
Complete special projects as required.
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Assist with the imaging of case information to ensure all documents are scanned and archived
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appropriately in compliance with internal standards and regulatory guidelines.
Adhere to CAPAs from the Quality, Training and Compliance (QTC) group.
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Walgreens Pharmacy, Lynn, MA Nov. 2007 – Dec. 2009
Pharmacy Intern – Part Time
• HIPAA Certified
• Completed many training courses offered by Walgreens
• Counseling patients, making doctor calls, inputting prescriptions from physicians, handling third party
claims, pick up, filling, orders, and inventory
• State Certified Intern License
• National Certified Pharmacy Technician License
• Patient safety/pharmacovigilance experience.
CVS Pharmacy, Billerica, MA Nov. 2004 – Dec. 2006
Pharmacy Technician
• HIPAA Certified
• Completed many training courses
• Counseling patients, making doctor calls, inputting prescriptions from physicians, handling third party
claims, pick up, filling, orders, and inventory
• National Certified Pharmacy Technician License
• Patient safety/pharmacovigilance experience.
• Very knowledgeable with various generic and brand name medications
Contact this candidate