Drug Safety Associate Resume

SUMMARY

ICSR Case Processing and Quality Review - Clinical trial reports, Post-marketing reports, Litigation reports, Partner reports,, regulatory authority reports and Product quality complaints etc.
Expertise in handling AgExchange, Arisg, Oracle Argus safety databases
Writing descriptive narratives
Proficient in using MedDRA and WHODrug
Good understanding of drug development process and Clinical trials
Excellent knowledge of disease processes and medical terminologies and ability to summarize medical information
Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations. Ability to follow ICH, CIOMS, FDA and EU guidelines, GCPs, standard operating procedures and safety guidelines
Ability to process high volume of cases
Ability to prioritize, plan and organize work assignments and able to work under strict timelines. Ability to work both independently and in collaboration with others
Proficiency in Microsoft Office Word, Power Point, Excel
Strong written and verbal communication skills
Good analytical, problem-solving and time management skills

PROFESSIONAL EXPERIENCE

Confidential

Drug Safety Associate

Responsibilities:

Performed data entry and quality review of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
As a case processor entered full case information on the Arisg and Argus safety databases, including quality review of reports and supporting documents to ensure accuracy and completeness.
Performed triage and classification of ICSRs for report type, seriousness, causality, expectedness/labeling and reporting, prioritize ICSR according to regulatory requirements
Performed single case unblinding, duplicate mergers and deletions after quality review, reviewed protocol updates for accuracy and made dechallenge / rechallenge determinations.
Performed adverse event coding using standardized terminology from a medical coding dictionary, such as MedDRA and coding of medications using WHODrug. Performed coding of diseases and adverse events according to the project-specific coding conventions in the Safety Database
Generated concise, accurate, chronological and well-written case narratives based on information provided both on standard forms and from medical records and other documents of diseases and medications.
Identified case corrections and created updates in the safety database following medical review
Ensured all cases that require expedited reporting are processed swiftly and appropriately within required timelines and ensured case receives medical review.
Identified significant missing information from reports and ensured its collection by sending follow up letters or queries where appropriate and ensured its closures.
As a quality reviewer performed quality review of adverse event reports from clinical study/trial, post marketing studies, spontaneous cases, partner cases, regulatory authority cases processed by other team members
Tracked completion of all assigned trainings by team members and performed additional duties as assigned within team.

Confidential

Pharmacovigilance Scientist

Responsibilities:

Performed triage, data entry and quality review of serious and non-serious adverse event reports from litigation cases, clinical trial, post marketing studies, spontaneous cases, partner cases, regulatory authority cases and also processed product quality complaints and device related issues
Performed case processing activities on safety databases AgExchange and Arisg (7.1)
Expertise in processing litigation reports with high accuracy within specified timeline and as per SOPs and project requirements
Worked as a quality reviewer for litigation cases and trained new members on a team into litigation case processing
Provided medical assessment to team members on medical records as required
Updated team on changes in labelling documents of assigned products. Completed short projects as assigned
Completed safety data entry for other report types with duplicate search, event ranking and coding using MedDRA, coding of diseases and medications using WHODrug.
Performed triage and classification of ICSRs for report type, seriousness, causality, expectedness/labeling and reporting, prioritize ICSR according to regulatory requirements
Written descript narratives and reviewed and updated auto-narrative as needed.
Generated follow up request and queries and ensured its closures.

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