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Deepika Gujre

@deepikagujre

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Experienced Drug Safety Associate with expertise in pharmacovigilance.

United States

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What I'm looking for

I am looking for a role that offers growth opportunities in pharmacovigilance and allows me to contribute to improving drug safety practices.

I am a dedicated Drug Safety Associate with over 3 years of experience in pharmacovigilance, specializing in the processing of adverse event reports, narrative writing, and compliance with global safety guidelines. My role has involved meticulous data entry into safety databases, including ARGUS and ARISg, where I ensure the accuracy and quality of safety reports in accordance with regulatory requirements.

Throughout my career, I have demonstrated my ability to manage complex case processing tasks, including triaging incoming cases, evaluating seriousness and expectedness, and preparing timely pharmacovigilance reports. I have actively participated in regulatory inspections and audits, showcasing my commitment to maintaining high standards of quality and compliance. My experience includes collaborating with cross-functional teams and external partners to enhance drug safety operations and ensure adherence to company policies.

Experience

Work history, roles, and key accomplishments

Drug Safety Associate

United Bio-Source Corporation

Oct 2022 - Jul 2024 (1 year 9 months)

Responsible for processing Individual Case Safety Reports (ICSRs), including initial review, safety database entry, and narrative writing on the ARGUS database. Evaluated cases for seriousness, relatedness, and expectedness, and assisted the PV management team with CAPA findings. Acted as a liaison with internal departments and external business partners on drug safety and pharmacovigilance case m

Argus SAE Coding Triage Regulatory Reporting CAPA Liaison

Drug Safety Associate

Parexel

Jun 2020 - Dec 2021 (1 year 6 months)

Performed case processing, including data entry, coding, and comprehensive narrative writing in the ARISg safety database. Coded medical history, drugs, and adverse event terms using MedDRA and WHO-DD, and validated SUSAR cases. Assisted in database reconciliation activities and ensured compliance with internal and global regulatory regulations.

MedDRA WHO DD Narrative Writing Regulatory Compliance Adverse Events

Education

Degrees, certifications, and relevant coursework

Clini Data Curve

Training, Pharmacovigilance and Drug Safety

Completed comprehensive training in Pharmacovigilance and Drug Safety. This program provided essential knowledge and skills for drug safety operations.

SYMBIOSIS CENTRE OF HEALTH CARE (SCHC)

Post Graduate Diploma, Hospital and Health Care Management

Obtained a Post Graduate Diploma in Hospital and Health Care Management (PGDHHM). This program focused on the administrative and operational aspects of healthcare facilities.

Dr. Hari Singh Gaur University

Bachelor of Pharmacy, Pharmacy

Completed a Bachelor of Pharmacy (B. Pharm) degree. The curriculum covered various aspects of pharmaceutical sciences, including pharmacology, medicinal chemistry, and pharmaceutics.