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Contact Manjinder K.

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Profile Details

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★★★★★

☆☆☆☆☆

USD 35 /hr

★★★★★

☆☆☆☆☆

Hire Manjinder K.

India

USD 35 /hr

Freelance Pharmacovigilance Analyst | Expert in ICSR management with 4.5 years of experience in Pharmacovigilance

Profile Summary

Experienced (4.5 +year) Analyst with a compelling attitude to work in stress conditions. Skilled in handling client queries, Pharmacovigilance, and data validation. Responsible for all safety-related aspects of a product- single case assessment, writing Market Authorization Holder (MAH) comments, Quality Review of ICSRs (Individual Case Safety Reports), and ERP handling.

• Possess good working knowledge of international drug safety regulations, including ICH & FDA guidelines, Volume 9A, Health Canada guidelines, CIOMS, European Union regulations, and guidelines.
• Expertise in management of Individual Case Safety Report (ICSR) that includes triage, initiation, Medical Review, Data Entry and Narrative writing (ADRs/ADEs), and Quality Review of ICSRs.
• Responding to safety requests from regulatory agencies or affiliates and liaising with the internal and external experts to obtain specialized medical expertise.
• Outstanding prioritization skills and multitasking ability to meet tight deadlines.
• Provided training and mentored PV scientists in various activities of case processing.
• Proficient in MS Office (Word, Excel, PowerPoint), MedDRA coding, WHO-Drug Dictionary, Micromedex, and possess expert knowledge of various drug safety databases (Argus, ARISg, and AWARE).
• Excellent communication skills along with good organizational, interpersonal, and presentation skills.

Subject Matter Expertise

★ Pharmacovigilance/Drug Safety Monitoring

Services

Writing

Writing Clinical Trial Documentation, Technical Writing

Work Experience

Pharmacovigilance Analyst

Parexel International

August 2015 - January 2020

Education

Master's in Pharmaceutical Chemistry

Punjabi University

July 2013 - August 2015

Bachelor's in Pharmacy

Punjabi University

July 2009 - June 2013

Certifications

Certification details not provided.