SAGAR LAMICHHANE, MD

acqv4z@r.postjobfree.com 215-***-****

Objective:

Seeking the position of a drug safety to utilize my interest, credentials and work experience in the medical field to upgrade my professional growth and development. Excellent communication, dynamic performance, proficient medical knowledge, strong clinical and therapeutic background and efficient time management skills are my strongest points which I can polish further by working in an organization that shall recognize my skills and allow me to flourish and reach my goal.

Key skills:

• Ability of processing and submissions of single case processing reports, and submissions of IND and NDA.

• Ability to follow ICH, FDA guidelines, GCPs, SOPs and safety guidelines.

• Fluent in scientific terms and also medical terminology.

• Proficient in data entry and drug safety database (ARGUS 7.0.2)

• Ability of processing the individual case safety report (ICSR).

• 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.

• Sound knowledge in coding medical terms using standardized medical dictionaries

(MedDRA).

Roles and Responsibilities:

• 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

• Receiving, processing and follow up of Adverse Events (AEs) and Serious Adverse Events

(SAEs) reports.

• Performs quality checks to ensure accurate case information is entered into safety database.

• Wrote comprehensive, concise and accurate narratives describing the adverse event reported.

• Initiated critical follow up requests, consulted and collaborate with internal colleagues.

• 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.

• Processed SUSAR cases from various sources such as clinical trial, post marketed, literature, and solicited with an accuracy and consistency at various stages of the system workflow.

• Generated aggregate and periodic reports such as IND/NDA, PSUR/CTPR, ensuring adherence to regulatory compliance timelines.

Professional Summary:

ICON, PA (APR 2014 UNTIL PRESENT)

Triage Officer

• Participated in the triage process of incoming adverse event cases to ensure timely and effective assessment and evaluation of cases.

• 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.

• Performed 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.

• Assessed the seriousness of the cases and reviewing the package inserts for expectedness.

• Performs data entry into safety database and code adverse events using MedDRA and product information using company product dictionaries.

• Performs quality checks to ensure accurate case information is entered into safety database and duplicate checks to avoid repeated reports.

• Receiving, Processing and follow up of Adverse Events (AEs) and Serious Adverse Events

(SAEs) reports from clinical trials and post marketing in accordance with company Standard Operating Procedures (SOPs).

• Assessing expectedness/listedness of adverse event according to Company core data sheet

(CCDS) for the product.

• Developed and maintained expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database.

• Generated queries using ARGUS interface for clarification, resolving and forwarding to next work flow and communicated to out side sources to retrieve the required information on the case report.

• Generated aggregate and periodic reports such as IND/NDA, PSUR/CTPR, ensuring adherence to regulatory compliance timelines.

• Processed SUSAR cases from various sources such as clinical trial, post marketed, literature, and solicited with an accuracy and consistency at various stages of the system workflow.

Sollers Institute

Drug safety intern (FEB 2013 MAR 2014)

• Performed Initial Case Entry/Case Booking, duplicate checks to avoid repeated reports and data entry into safety database ARGUS.

• Performed manual coding of AEs using MedDRA dictionary for the events that were auto encoded and code product information using company product dictionaries.

• Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow up requests.

• Developed, maintained and expanded medical/scientific and regulatory knowledge required to support drug safety activities.

• Processed cases with an accuracy and consistency at various stages of the system workflow.

• Determined and performed appropriate case follow up, generating and requesting follow up letters.

• Assessed cases to distinguish those with particular complexities and /or specific issues, and escalated to the respective team or an individual.

• Contribution in drafting regulatory documents such as IND and NDA.

• Reviewed, ranked, verified, process and document: event terms; case classifications

(validity, seriousness, and expectedness/listedness/labelledness); special scenarios; product compliant information; report ability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.

• Prepared clinical narratives summaries for adverse event (AE) reports independently from clinical studies and spontaneous post marketing reports.

• Performed necessary follow up for missing, discrepant or additional information from source documentation.

Education:

Drug safety program with ARGUS training

Sollers Institute

Formerly known as clinical research academy of America MD in general medicine

Saint Petersburg State Pediatric Medical Academy

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