Role & responsibilities Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO), Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs)] or other scheduled or unscheduled reports, as required Medical review of IC SRs for marketed and investigational human and veterinary products, ensuring accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding) Preferred candidate profile MBBS / MD - Must have experience of 3-5 years for medical review of IC SRs primarily Location : Remote #J-18808-Ljbffr Randstad
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