Safety Medical

Shashi Email: *****.*********@*****.*** Phone : 516-***-****

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 Anti-infective, CNS, CV, Metabolic, and Oncology

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.

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.

Reviewed adverse drug experience reports and entered into the safety databases like (ARISg, ARGUS) and the follow-up requests, coding adverse events in MedDRA in conjunction with medical monitors.

Assisted in submissions of case reports via the CRO to regulatory authorities.

Contributed in the timely preparation of case reports for DSURs (Developmental Safety Update Reports), SUSAR Line-Listing Reports and IND annual reports

Ability to summarize medical information in a concise manner.

Initiate, own, investigate, process, and monitor the status of CAPA's for pharmacovigilance.

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 interpersonal, organizational, verbal and written communication skills.

Extensive Experience in working with MS Visio, PowerPoint, Word and Excel.

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

Technical Skills:

AERS: ARGUS, ARISg

Sharepoint, MS Office (Word, Excel, PowerPoint, Outlook)

Inventiv Health Aug 2014 to Present

Drug Safety Associate

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, Vaccines, Neuroscience, CV, 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

Spectrum Pharmaceutical, CA. January 2013 – June 2014

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.

Assisted CROs in the events receipt, assessment, tracking, follow-up, and regulatory reporting of adverse drug experiences.

Triaged the adverse events for expectedness

Reviewed adverse drug experience reports entered into the Safety Database by a CRO. Review the narratives, follow-up requests, and coding adverse events in MedDRA in conjunction with medical monitors and prepare line-listings and narratives as requested for safety reviews

Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations

Narrating safety aggregate reports which includes ICSRs, PADER, PSUR and DSUR. Initiate,

own, investigate, process, and monitor the status of CAPA's for pharmacovigilance.

Performed Safety and Risk Management on study teams for safety activities, including safety updates, data review, and meeting participation.

Reviewed for safety operations on cross-function documents, including study protocols, study reports, and regulatory reports.

Worked in PVER an submitted the report according depending upon the seriousness of the cases.

Processed cases in therapeutic areas of Oncology.

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.

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

Sunovion, MA May 2011 – Dec 2012

Drug Safety Associate

Responsibilities:

Documented and processed serious adverse events; spontaneously reported adverse events and; other medically related information per study specific procedures.

Assisted CROs in the events receipt, assessment, tracking, follow-up, and regulatory reporting of adverse drug experiences and also triaged the adverse events

Monitored the company’s clinical trial drug surveillance program including the intake, evaluation, processing and follow up of serious adverse event reports.

Wrote case narratives, selected preferred terms matching MedDRA listings reported adverse events.

Processed cases in therapeutic areas such as CNS and Respiratory diseases.

Performed safety review of clinical data (case report forms) and reviewed CRFs for data issues and inconsistencies.

Reviewed adverse drug experience reports and entered into the Safety Databases.

Reviewed the follow-up requests, coding adverse events in MedDRA in conjunction with medical monitors.

Prepared SUSAR line-listings and also helped in narratives by performing safety reviews.

Assisted in submissions of case reports via the CRO to health regulatory authorities.

Assisted with development of periodic safety reports, including CSR production, periodic clinical trial reports, and periodic post-marketing safety update reports.

Participated in compliance activities related to Safety and Risk Management and the Global Safety System.

Participated and initiated updates to Global Safety System.

Contributed in the timely preparation of case reports for DSURs (Developmental Safety Update Reports), 6-monthly SUSAR Line-Listing Reports and IND annual reports

Received and logged safety reports from sites; reviewed them for completeness; and made a preliminary assessment of the need for expedited reporting.

Entered safety report data into the company’s serious adverse event reporting database; and used clinical judgment to code medical terms and drug terms using MedDRA and WHO Drug Dictionaries.

Followed-up safety reports until adverse event resolution or stabilization.

Provided input for and reviewed relevant safety tracking systems for accuracy and quality.

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

Environment: ARISg

AuroBindo, India. August 2009 – August 2010

Drug Safety Associate

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 Qualifications:-

Master’s Degree in Biomedical Sciences, LIU cw post, NY

Bachelor of Science in Pharmacy, Rajiv Gandhi University of health sciences

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