Manjinder Kaur

WORK HISTORY

EDUCATION

SKILLS

ABOUT MANJINDER KAUR

OBJECTIVE- To acquire the knowledge for upgrading my capabilities to work sincerely, efficiently by applying my skills to the best of my ability for the benefit of mankind, and to be a positive contributor to the growth of my organization. SUMMARY: Experienced (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. Looking forward to more opportunities for career advancement.