SAGAR LAMICHHANE
CELL - 682-***-****
EMAIL – acfk5y@r.postjobfree.com
Professional Summary:
A combination of 5 year experience as drug safety associate, clinical & safety associate and
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medical products associate with experience of processing and submissions of single case
processing reports, and submissions of NDA’s and ANDA’s.
Ability to follow ICH, FDA guidelines, GCPs, GLPs, standard operating procedures and safety
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guidelines
Fluent in scientific terms and also medical terminology.
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Proficient in data entry and drug safety databases (ARGUS, ARISg).
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Assisted in preparing the periodic safety reports (PSUR) and processing the individual
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case safety report (ICSR).
Knowledge of key Clinical Safety and Pharmacovigilance (CSPV) responsibilities including:
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Collecting, documenting, and processing of adverse event (AE) reports from clinical trials and
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post-marketing sources;
Reconciliation SAEs between drug safety and clinical trial databases;
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Generated concise, accurate and well-written case narratives.
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Responsible for effective and efficient development of the safety management plan, including
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development of specific processes to assure consistency within the project.
Triaged every report to confirm the validity of the case and decide on the timelines in
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accordance with the regulatory requirements for submission and company specific standard
operating procedures
Prepared case narratives in accordance to CIOMS V, particularizing information that is
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medically relevant to the adverse events reported
Handled Clinical SAE, Spontaneous reports and PMS studies individually with their Quality
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review
Sound knowledge in coding medical terms using standardized medical dictionaries
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(MedDRA) and drugs using WHO Drug Dictionary.
Ability to work in a fast paced organization and maintains time lines for multiple projects.
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Knowledge on making aggregate reports.
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An effective communicator at all levels within the organization.
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Professional Experience:
ASTROGENETIX, Austin, TX
Drug Safety Associate (05/2013 – Till date)
• Participated in the triage process of incoming adverse event cases to ensure timely and
effective assessment and evaluation of cases
• Assessed the seriousness of the cases and reviewing the package inserts for
expectedness
• Performed duplicate checks to avoid repeated reports
• Assessed causality and coordinated with the medical team for clarifications
• Performs data entry into safety database and code adverse events using MedDRA
and product information using company product dictionaries and WHO-DD
• Performs quality checks to ensure accurate case information is entered into safety
database
• Wrote comprehensive, concise and accurate narratives describing the adverse event
reported in source documents
• Initiated critical follow-up requests, consulted and collaborate with internal colleagues
• Ensured that expedited reports are processed and sent to regulatory affairs department
within established timelines
• Ensure reports are compliant with ICH guidelines, FDA requirements, and internal SOPS
• Participated in periodic review and updating of SOPs and working practices to ensure
they remain compliant
• Developed, maintained and expanded medical/scientific and regulatory knowledge
required to support drug safety activities.
COVANCE, Austin, TX
Drug Safety Associate (4/2012 – 2/2013)
• Perform manual triage of non-serious cases to ensure the accuracy of that determination
with the potential to upgrade to serious for higher level medical review.
• Create comprehensive narratives procured from relevant, related information from various
source documents.
• Triaged every report to confirm the validity of the case and decide on the timelines in
accordance with the regulatory requirements for submission and company specific standard
operating procedures
• Completing full case information on the database ensuring quality by accuracy and
completeness of each case
• Preparation of case narratives, in accordance to CIOMS V, particularizing information that
is medically relevant to the adverse events reported
• Receiving, processing and follow up of Adverse events(AEs) and Serous Adverse
events(SAEs) reports
• Coding of medical history, drugs and reported adverse event terms in safety database
using medical dictionaries (MedDRA) and assessing expectedness/listedness of adverse
event according to CCDS for the product.
• Review of previously entered data and completion of data entry including writing adverse
event case narrative summarizing the essential details of the case.
• Processing and reporting of spontaneously reported adverse drug reaction as well as
company sponsored clinical trials according to the guidelines and SOPs documented by the
company to the health authorities within the reporting timelines.
• Accurate coding of incoming serious and non-serious adverse events using MedDRA
terminology.
• Coding of medical terms using standardized medical dictionaries and drugs using WHO Drug
Dictionary.
• Assess follow-up, lock, and distribute/archive non-serious cases.
• Maintain continuous knowledge expertise in local and global requirements for safety reporting.
• Ensured timely coverage of incoming cases to Regulatory Authorities.
• Participating in the aggregate report preparation with the study director.
PRATHIVARA MEDICAL CENTER, Kathmandu, Nepal
Medical officer (07/2001-12/2005)
• Performed general medical checkup, basic diagnostics, and medical certificates.
• Checked 15-20 outpatients daily, conducted diagnostics, and referred patients for
hospitalization as needed.
PENAL REFORM INTERNATIONAL, Kathmandu, Nepal
Medical officer/ Volunteer( 01/2004-12/2004)
• Provided health education to approximately 10 workers and 30 prisoners concerning
infectious disease.
• Checked patients and provided referrals to the nearest hospitals as needed.
NEPAL MEDICAL COLLEGE TEACHING HOSPITAL (NMCTH)
Attarkhel, Jorpati, Tel # 486008, Internet : www.nmcth.edu
Kathmandu, Nepal House officer ( 09/2000-06/2001)
• Managed outpatients, diagnostics, and handled admitting. Initiated treatment of
inpatients, attended rounds, wrote discharge notes and arranged follow- up care.
MINISTRY OF HEALTH
Kathmandu, Nepal Intern ( 08/1999- 07 /2000)
• Completed internship training programme in different govermental hospitals in the
following different departments – General medicine, General Surgery, Pediatrics, Ob – Gyn,
Emergency, Orthopedic, ENT, Opthalmology, Tropical and Infectious Disease.
E ducation:
MD in general medicine
Saint Petersburg state pediatric medical academy,Russia