Identification of safety-relevant publications in the scientific literature. Provision of scientific input in the course of YES' literature surveillance service.
Creation of response documents in reply to authorities' assessment reports to PSURs and in the course of marketing authorisation application and/or renewal procedures.
Review of literature and review and summary of large safety data sets and presentation of results in draft reports.
Creation, review and submission of ICSRs/CIOMS-I forms.
Single case management with regard to adverse drug reaction reports arising from clinical trials, spontaneous reports or literature, expedited and non-expedited reporting of adverse drug reactions.
Creation of PSURs (Periodic Safety Update Reports) and associated documents such as Addendum to the Clinical Overview.
Creation of various scientific statements focused on individual questions regarding safety-related aspects of drugs (e.g. Risk Management Plans, Signal Detection Reports).
Writing and review of scientific and medical reports.
Preparation and review of Clinical Expert Statements.
Communication with regulatory authorities.
Provision of medical advice to client companies with regard to all pharmacovigilance-focused aspects.
Signal detection.
Safety and benefit-risk evaluations for assigned products.
Management of potential safety issues for assigned products.
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