Bhavini Gami

adwi0l@r.postjobfree.com

Cell:774-***-****

PROFESSIONAL SUMMARY

** ***** ** ******* **********. Excellent critical thinking and quick decision making skills. Experienced in the biotech industry specially clinical trial and post marketed products in multiple therapeutic areas. Understand and interpret complex clinical data and have a passion for patient safety. Certification in drug safety and pharmacovigilance,aiming to utilize my medical education and skills that I learned from my nursing career to full potential in an endeavor to improve drug safety and make a difference to patient health, while meeting organizational goals and standards. EXPERIENCE

Clinical Safety Reviewer (Client: Sanofi Pharmaceuticals) Oct 2021 –Present, Covance Princeton, NJ

• Performing medical review of clinical trial cases including prioritization and determining regulatory reporting

• Performed duplicate case search and accurately captured patient, product, and event data in Oracle Argus safety 8.0.

• Triaged and coded medical history, laboratory and other investigational test results, adverse event terms using MedDRA and WHO drug dictionary

• Performed appropriate case follow-up, generating, and requesting follow-up letters.

• Performing coding and expectedness of the Adverse events with reference-to-reference safety documents(IB, CCDS, SmPC, USPI)

• Perform reviewing of narratives for medical coherence and providing comments in accordance with company's requirements.

• Perform Reviewing and Quality Check of Individual Case Safety Reports

(ICSR)for serious adverse events (SAE) and non-serious adverse events for accuracy and clarity.

• Identify and medical review SUSAR cases (Causality assessment) based on product knowledge and medical judgment.

• Updating data sheets for upload to safety database as per current RSI updates

• Work closely in coordination with other departments in proper gathering, evaluation, medical assessment, and follow-up of individual case safety reports.

• Performing any other drug safety related activities as assigned and assisting with the preparation of relevant training material.

• Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the client Global Safety Database, and Argus Safety.

• Understanding of applicable regulations, including FDA (21 CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc.

2

Licensed Practical Nurse - July 2013 to present

Pediatric nurse

• Telephonic triage (assessment,planning, scheduling,taking care of patient’s needs, ER follow up, lab/xray/imaging study results and follow up calls etc.)

• Patient care: outpatient clinical care (taking vitals,administering meds,vaccines,injection,specimen collection,swabs,PCR testing etc.)

• Prior Authorization experience

• Aseptic lab technique(following Standard operating procedure)

• Mental and emotional care

• Phlebotomy experience

EDUCATION

• LPN (Nurse)

Mass Bay Community College

Framingham, MA 2012

• Post Graduate Diploma certificate-Medical Lab Technician Gujarat University

Ahmedabad, INDIA 2003

• Bachelor of Science Degree - Chemistry

Gujarat College (Gujarat university).

Ahmedabad, INDIA 2002

CERTIFICATION

• Certification in Advanced Drug Safety and Pharmacovigilance SKILLS

• Effective cross-team collaboration.

• Independent judgment and decision making.

• Strategic planning capabilities.

• Excellent Communication skills.

• Proactive and innovative problem solving.

• Critical thinking and problem solving skills.

• Highly adaptable to dynamic work environments.

• Able to work independently and as part of a team. LANGUAGE

• English

• Hindi

• Gujarati

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