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Rajni Saini

@rajnisaini

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Pharmacovigilance Analyst with expertise in drug safety management.

India

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What I'm looking for

I am looking for a role that allows me to leverage my pharmacovigilance expertise while contributing to a collaborative team environment focused on drug safety and regulatory compliance.

I am a dedicated Pharmacovigilance Analyst with extensive experience in managing Individual Case Safety Reports (ICSRs) within the Oracle Argus Safety Database. My career began as a Pharmacovigilance Scientist, where I honed my skills in triaging ICSRs, conducting duplicate searches, and ensuring compliance with global regulatory requirements. I take pride in my ability to maintain operational efficiency and quality in all aspects of my work.

Throughout my career, I have developed a strong understanding of international drug safety regulations, including ICH guidelines and FDA requirements. I am proficient in MedDRA coding and have successfully prepared for internal and external audits. My academic background in Medicinal Chemistry complements my professional expertise, allowing me to approach challenges with a comprehensive understanding of pharmaceutical sciences.

Experience

Work history, roles, and key accomplishments

Current

Pharmacovigilance Analyst

Current

Continuum India LLP

Apr 2024 - Present (1 year 2 months)

Manages Individual Case Safety Reports (ICSRs) within the Oracle Argus Safety Database, including triage, duplicate searches, data entry, and quality review. Ensures timely submission to regulatory authorities and adherence to client guidelines and global regulatory requirements.

Oracle Argus Safety ICSR Management Regulatory Reporting Data Entry Quality Microsoft Office

Pharmacovigilance Scientist

Continuum India LLP

Sep 2021 - Apr 2024 (2 years 7 months)

Oversaw the comprehensive management of Individual Case Safety Reports (ICSRs) in Oracle Argus Safety Database, encompassing case review, quality review, and follow-up activities. Reviewed product coding, case seriousness, and adverse event expectedness against various labeling documents, while also training staff and preparing SOPs.

Oracle Argus Safety ICSR Management Regulatory Compliance SOP Development Training

Education

Degrees, certifications, and relevant coursework

Jaypee University of Information Technology

Master of Pharmacy, Medicinal Chemistry

Completed a Master of Pharmacy with a specialization in Medicinal Chemistry. Gained advanced knowledge in drug design, synthesis, and analysis.

Himachal Institute of Pharmacy

Bachelor of Pharmacy, Pharmacy

Obtained a Bachelor of Pharmacy degree, focusing on pharmaceutical sciences and drug development. Developed foundational knowledge in pharmacology, pharmaceutics, and medicinal chemistry.