Lubna Kadiri
Drug Safety Associate @Clinexel
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WORK HISTORY
Drug Safety Associate @Clinexel
Navi Mumbai, IN
Conducted comprehensive literature monitoring, including analysis of medical publications, scientific journals, and newsletters. Performed case processing tasks such as triage, duplicate checks, and quality review of ICSRs.Documented findings from various sources and prepared reports related to medicinal products and devices.Prepared Signal Reports for pharmaceutical products based on the annual calendar, utilizing various source documents such as PRAC meeting minutes, drug safety alerts, and baseline listings from the database.Assisted in the preparation and drafting of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and clinical safety documentation.
EDUCATION
Cliniminds
Diploma
Oriental Education Societys College of Pharmacy Sanpada Navi Mumbai
Bachelor of Pharmacy (B.Pharm.)
ABOUT LUBNA KADIRI
Good knowledge of pharmacovigilance system.(including all terminologies, definitions, guidelines, process)Hands-on experience operating PV software Clinevo safety database.Experience in Literature monitoring (Local Literature from Journals and Newsletter, National PubMed Search), Case processing, Triage & Review, Narrative writing.Good knowledge about MedDRA codingGood understanding of ICH GCP Guidelines, Good pharmacovigilance practice (GVP) modules, PvPI guidelines, Phases of clinical trials, drug development & discovery process, protocol designing, Essential documents and ICD proccess.
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