Pharmacovigilance expert - 13 years experience
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I am having 13 years of experience in pharmacovigilance with the following expertise:
Subject matter expert for Global ICSR automation tool
Good leadership, analytical, problem-solving and time management skills.
Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.
Proficient in MS Office, in using MedDRA medical coding and WHO Drug Dictionary.
Expertise in managing Individual Case Safety Reports (ICSRs)- serious and non-serious
(spontaneous, clinical studies, and retrospective programs) on Product Safety Databases for
Adverse Events like Oracle AERS and ARGUS
Regulatory Compliance management for Patient Support programs (PSPs) and Market
Mentoring PV scientists in various activities of case processing.
Exceptional interpersonal skills, fostering a positive work environment and promoting open communication.
Subject matter expert for Global ICSR automation tool
Good leadership, analytical, problem-solving and time management skills.
Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.
Proficient in MS Office, in using MedDRA medical coding and WHO Drug Dictionary.
Expertise in managing Individual Case Safety Reports (ICSRs)- serious and non-serious
(spontaneous, clinical studies, and retrospective programs) on Product Safety Databases for
Adverse Events like Oracle AERS and ARGUS
Regulatory Compliance management for Patient Support programs (PSPs) and Market
Mentoring PV scientists in various activities of case processing.
Exceptional interpersonal skills, fostering a positive work environment and promoting open communication.