Pratibha Handa

Background

About Pratibha Handa

Drug safety physician with 12 years of Pharmacovigilance experience involving ICSR processing (spontaneous, post-marketing, literature, and clinical trial, Nutraceuticals, Cosmeceuticals), Signal Detection and Safety Surveillance, Risk Management, aRMMs, Medical information processes, Literature assessment-global and local, Aggregate reports, Reconciliations, digital patient support programmes, patient safety lead, and local affiliate responsibility. Educational qualification include MBBS and MD in Pharmacology, diploma in Diabetes management and registered with Medical council of India and Delhi Medical Council. In depth knowledge of GVP modules and regulatory guidelines, Worked with Pharmacovigilance CROs at the very foundation stages and was involved in the setting of PV system, SOP/WI authoring, reviewing, database validation, training and mentoring of new team members including beginners as well as experienced team members, Have worked very closely with QPPVs, LPPV, and provided support to them, as required. Writing and reviewing reports and statements for submission to FDA, EMA, Health Canada and other stakeholders. Authoring and review of clinical trial documents like Working instruction, IB updates, Narrative templates, Reconciliation, AOSE, SMP, ICFs, SAE intake, Pregnancy follow-up forms, CSRs, Abbreviated narratives, DSUR. Post Marketing Documents: RMP, PSUR/PBRER, SmPC updates, Dear HCP letters, training materials and PPTs, COVID-19 vaccine support: Draft of work instruction, TFQs, database validation, Signalling, ADR Follow-up forms, training, and support to team members, Support for on-site or remote audit for PV systems, Project management, meetings, presentation, communications, and coordination with client, resource and time management, Experienced in PV databases: Argus, ARISg, Basecon, EMPIRICA.