プロフィール詳細

プロジェクトを作成

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Manjinder K.に依頼

India

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

プロフィール概要

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.

専門分野

• ★ Pharmacovigilance/Drug Safety Monitoring

サービス

• Writing

Writing Clinical Trial Documentation, Technical Writing

職務経験

Pharmacovigilance Analyst

Parexel International

8月 2015 - 1月 2020

学歴

Master's in Pharmaceutical Chemistry

Punjabi University

7月 2013 - 8月 2015

Bachelor's in Pharmacy

Punjabi University

7月 2009 - 6月 2013

認定資格

• 認定資格の詳細は未入力です。