Data Entry Safety

PH- 903-***-****

HANI YALAMANCHILI

*******@*****.***

Professional Summary:

• More than 4 years of drug safety experience in processing both clinical and spontaneous adverse

event cases in AERS (adverse event reporting systems) like ARGUS and ARISg in

pharmacovigilance field.

• Exposed to various therapeutic areas as Oncology, Cardiovascular and Immunology.

• Processed safety reports from all sources for assigned products according to ICH-GCP and FDA

guidelines.

• Extensive knowledge on clinical trials (Phase I-IV), pharmacovigilance principles and

regulations.

• Well versed in using different adverse event reporting databases including ARGUS, ARISg.

• Experienced in triage, duplicate check, data entry, coding of adverse events and drugs, narrative

writing, quality check and reporting.

• Proficient in coding of serious and non serious adverse events using MedDRA terminology and

drug coding in accordance with WHO-DD and company core dictionary.

• Experienced in preparing and submission of adverse event reports, safety aggregate reports and

PSUR’s.

• Expertise in performing case closure and AE/SAE reconciliation.

• Good knowledge on IRB services and GCP guidelines.

• Ability to apply sound analytical thinking and database query skills to gather, summarize, and

evaluate critical information.

• Ability to summarize medical information in a concise manner.

• Comprehensive knowledge of drug safety and drug development process and procedures.

• Good team player, consistent, flexible, committed to work and has the desire to take

responsibilities and fulfill them effectively.

• Excellent written, oral communication and strong organizational skills.

• Good leadership skills including training, motivating staff members to achieve company safety

objectives.

Technical Skills:

AERS: ARGUS, ARISg

MS Office (Word, Excel, PowerPoint, Outlook)

CAREER EXPERIENCE:

Ironwood pharmaceuticals, MA March 2013 - Till Date

Drug Safety Specialist

Responsibilities:

• Evaluation and processing of adverse event reports from post marketing and clinical sources in

accordance with FDA and ICH guidelines.

• Triaging (Completeness, legibility, reportability) of Individual Case Safety Reports (ICSR) to

determine seriousness, expectedness and causality and request for follow ups through phone, fax,

and mail.

• Performing the data entry to the cases in ARGUS database after ensuring the validity of the

reports with minimum set criteria and carry duplicate detection.

• Assessing the seriousness of cases and MedDRA coding for serious events with appropriate and

preferred terms, from the source documents.

• Writing Precise Case narratives for spontaneous, clinical and literature.

• Perform follow-up (telephone, e-mail or facsimile), as needed, either directly with reporter,

through call center, or through appropriate CRAs, and documents results in case file.

• Ensure that required follow-up for assigned cases has been completed.

• Performing quality check of adverse event reports for seriousness, causality and expectedness as

per the Investigator Brochure/ US package insert.

• Assisted in writing Safety aggregate reports and some sections of PSURs.

• Performed appropriate due-diligence.

• Verifying and reviewing all forms and documents pertaining to a case for errors, missing

information, legibility.

• Performing daily responsibilities in compliance to all applicable Standard Operating Procedures

(SOPs), regulatory requirements, conventions, and company policies.

• Communicate with partner companies, collaborative sponsors and their respective clinical

research organizations (CROs) regarding the evaluation and processing of case reports.

Environment: ARGUS

Sunovion, MA January 2011 - February 2013

Drug Safety Associate

Responsibilities:

• Working knowledge of relevant FDA, and ICH guidelines, initiatives and regulations governing

both safety reporting and processing clinical trial and post-marketing environments.

• Demonstrated competence in processing, evaluating and reporting safety information in

compliance with the regulations.

• Performed data entry of identified adverse event information and ensured the uniform and timely

processing of adverse events to regulatory authorities.

• Ensured the accurate classification of all SAE as needed.

• Working knowledge of MedDRA dictionary with relevance to adverse event coding preferred.

• Generated case narratives derived from the collection of adverse event information and verified

medical coding in the safety database system.

• Assisted in preparing the periodic safety reports (PSUR) and processing the individual case safety

report (ICSR).

• Responsible for assessment of incoming case reports and source documentation for completeness,

accuracy, legibility, and consistency of information, and performs necessary checks for duplicate

cases.

• Liaised with investigator and other trial associates for clarifications of queries and for clinical

trial updates.

• Assisted in performing listing the criteria for AE/SAE reconciliation.

• Assisted in the development and maintenance of departmental SOPs, policies and implementation

guidelines.

Environment: ARGUS

AuroBindo, India. January 2010 – December 2010

Drug Safety Coordinator

Responsibilities:

• Responsible for evaluation and documentation of initial and follow-up AE documents.

• Ensured consistency with the source documentation.

• Triage the cases of potential adverse events & check reports for completeness and accuracy.

• Processed cases in therapeutic areas such as Anti-infective, CNS, CV, Metabolic, and Oncology.

• Responsible for processing collected global AEs/SAEs on wide variety of products.

• Entered safety report data into the company’s serious adverse event report database; and used clinical

judgment to code medical terms and drug terms using MedDRA and WHO-DRUG Dictionaries (WHO-

DD) respectively.

• Reviewed CRFs for data issues and inconsistencies.

• Generated queries for follow-up reports.

• Generated concise narrative case summaries in Pharmacovigilance database according to company

standards.

• Determine appropriate regulatory reporting requirements under the global regulatory and guidelines (FDA

regulations and ICH guidelines).

• Conducted Quality Review of other safety assistant’s SAE cases data entry and tracking processing.

• Performed maintenance of accurate and through documentation.

• Assisted in writing SOP’s and training material for newly hired drug safety professionals.

• 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.

Environment: ARISg

EDUCATIONAL QUALIFICATION:

• Bachelors of Dental Surgery from Rajiv Gandhi University, Bengaluru, India.

• Masters in health administration from Webster university, St louis, Mo.

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