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Prior to Vigi Medsafe
- Extensive clinical and pharmaceutical industry experience of 11 years
- Novartis – Pharmacovigilance Expert in Drug Safety team with significant experience in databases such as Argus, Empirica Monitored safety profile of products including PSURs, RMPs, signal detection, responses to health authorities, review of clinical protocols, and responsibility for the clinical review and evaluation of cases (> 20,000 ICSR’s from Spontaneous, Clinical trial, Literature), Addendum Reports, Core Data Sheet updates, etc.
At Vigi Medsafe
- Complete oversight of Medical function
- On-boarding and training new comers on GVP modules related to medical function
- MedDRA training to both medics and non medics
- Creation of various templates of safety related documents as per ICH guidelines
- Medical review (including label assessment at event and case level) and comment of ICSRs and identification of SUSAR
- Signal detection from ICSRs, literature and other sources and authoring of signal evaluation reports
- Literature screening and medical judgement and identification of ICSRs
- Signal tracker tool and development of signal review schedules
- Setting up safety review meetings to update clients’ representatives and QPPV
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