- 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.
Review of literature and review and summary of large safety data sets and presentation of results in draft reports
Creation of PSURs (Periodic Safety Update Reports), PBRERs and associated documents eg Clinical Overview and Addendum to the Clinical Overview.
Creation of Annual Safety Reports (ASRs) or Development Safety Update Reports (DSUR).
Creation, review and submission of ICSRs/CIOMS-I forms.
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.
Writing and review of standard operation procedures in drug safety department.
Keyskills
Desired Candidate Profile
Education-
- Please refer to the Job description above
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