Safety Analyst

Dr. Vaishnavi Muthukumar

201-***-**** (M) ********@*****.***

Summary:

A healthcare professional, proficient in drug safety and pharmacovigilance principles and regulations

Proficient in case processing (unsolicited, solicited and literature reports) Case triage, case entry of individual case safety reports, and electronic submissions received by registries and post-marketing sources.

Through understanding of the drug development process, FDA, US and ICH safety reporting regulations, GCP guidelines, EU-EMEA and HIPAA guidelines.

Capable of tracking serious adverse events, serious and non-serious adverse drug reactions, and other medically related project information

Technology Capabilities:

Software Expertise: Oracle Argus, Oracle Health Sciences Empirica Signal

Databases Experience: Oracle, SQL

Project Management Tools: MS Excel, MS word, MS Power Point, Project Planning Tools (Microsoft Project Plan), Collaboration Tools (Microsoft SharePoint)

Operating Systems: Windows

Education and Certifications:

Advanced Drug Safety and Pharmacovigilance Program – Sollers– Edison, New Jersey

Bachelor of Dental Surgery from Sri Ramachandra Medical University, Chennai, India

Member of Indian Dental Association.

Licensure: Dental Council of India

Professional Experience:

CRR and Triage Analyst: (Jan 2018 till present) Cognizant Technology Solutions ( Sanofi-Aventis –Bridgewater, NJ)

Supervise publishing of correspondence to reporters of adverse event cases, as well as any subsequent follow- up information as requested by ASA/ASO role or GPE.

Oversee the distribution of workload assigned to the coordinator for Case Receipt and Retention in order to ensure maintenance of regulatory response timelines..

Maintaining a case file retrieval system that is efficient and ensures document management, including identification and implementation of database updates for process improvement/efficiency.

Assisting Triage Manager with tracking, prioritization, and distribution of PTC investigation reports.

Evaluating findings and recommend changes or modifications in procedures, utilizing knowledge of USPV functions, coding and filing methods. Recommend purchase of storage, retrieval or disposal.

Oversight for ongoing maintenance of technical user manuals and documentation for Tracking Database and Record Retention process manuals.

Liaise with Leadership to identify significant workload volume shifts and to recommend strategies to manage any significant increases.

Liaises with other functional areas such as Safety Physicians, Training, and Quality. Interacts as needed with external departments such as Medical Information, Legal, Sales representatives, Customer Service, Regulatory

Triage spontaneous and certain clinical trial cases to the appropriate case registration queue.

Triage drug and medical device adverse events based on seriousness criteria

Identifying if reported adverse events and product technical complaints are related or independent of each other

Ensure that the tracking of inflow of cases and triage of initial and follow-up information received are processed in a timely manner, consistent with SOPs.

Evaluating current and proposed processes/procedures to identify quality and efficiency improvements.

Investigating compliance issues related to the triage of case information.

Drug Safety Associate : (Jun 2016– Dec 2017 ) Sollers - Edison, NJ

Investigated, evaluated, and followed up on case reports associated with safety of investigational and marketed drugs.

Capable of triaging, data entry, medical review, bio statistical analysis and reported adverse events using Oracle Argus version 8.0 and Empirica signal

Prioritized of cases to ensure regulatory reporting timelines are met

Collaborated with healthcare professionals and management staff to ensure timely completion of tasks

Conducted audits checks for global safety database in accordance with the SOPs for all ICSRs to prevent duplication of existing case filing

Created electronic case report files for new cases and assessing reports for seriousness, causality and expectedness, prioritizing adverse event report processing based on the ICH GCP guidelines, writing case narratives summarizing the essential details of the case, generating queries pertinent to the case

Provided inputs for documenting Standard Operating Procedures and Work Practices

Performed literature searches utilizing PubMed and other databases to answer questions received by external professionals

Coded adverse drug experiences using MedDRA version 19 and WHO Drug Dictionary

Contributed to preparation and review of periodic safety reports and other safety related documents (Drug Safety Reports, Ad hoc analyses requested by Regulatory Authorities) in accordance with regulatory requirements and standard operating procedures

Prepared expedited and non-expedited reports to regulatory authorities in accordance to SOPs and regulatory requirements

Performed signal detection activities in EMPRICA

Pharmacovigilance and Risk Management planning for designated products by analyzing the risks, preparation of safety strategies and highlighting and tracking potential issues

Dental Assistant: (Feb 2012 to Mar 2013) Smile Center - Dr. Shankar Iyer – Jersey City, NJ

Triaged cases, accurately updated and maintained case reports

Handled patient queries and recorded appropriately

Booked in patients, entered patient’s details and investigational reports in the database

Monitored patients for adverse events

Documented and reported adverse events

Performed office administration function as required

Performed intraoral x-ray and analyzed and documented the x-ray findings

Assisted the chief in minor oral surgical procedures

Lead Dentist: (June 2006 to May 2011) AV Dental Hospital - Dr. Ranjini - Chennai, India

Provided emergency/palliative care, comprehensive dental care, examinations, and evaluations in a multi-chair clinical setting

Performed monthly record audits on provider charts and provided training on dental record standards

Managed and approved off-site dental referrals; audited and conducted quality assurance examinations on patients upon completion of treatment

Perform all aspects of general dentistry including restorative, periodontics, prosthodontic, endodontic, and surgical procedures

Volunteer Experience:

Volunteered for several Medical and Dental camps as part of Corporate Social Responsibility programs

Created awareness programs for health professional and patients regarding reporting of adverse events/reactions in India

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