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

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