Signal Manager (m/f)

REFERENZNUMMER:

324191/1

IHRE AUFGABEN:

-Development, maintenance and ownership of efficient GDS processes related to signal management, in compliance with legislations and appropriately described in Quality Documents
-Development and maintenance of a formalized benefit-risk assessment approach, compliant with regulatory requirements, consistent in general principles but tailored in specifics to meet individual product needs
-Development and maintenance of templates of high quality for documentation of relevant steps in the process and preparation of respective documents such as Signal Evaluation Report and Benefit-Risk Assessment Report
-Provision of medical safety expertise to the development and maintenance of tools for signal detection, e.g. quantitative signal detection methods, signal detection based on data from clinical trial databases
-Implementation and management of a tracking tool to ensure progress of decision-making for all potential signals, so that all identified and potential risks are appropriately addressed with risk mitigation actions, according to the agreed timelines; to ensure that corrective actions are implemented if any of the timelines are at risk
-Development and production of periodic summary reports of compliance with the signal management process, measuring the proportion of signals that were delivered in compliance with the timelines, providing a root cause analysis and a CAPA plan for any instances of non-compliance, and ensuring the delivery and evaluation of the effectiveness of these CAPAs

IHRE QUALIFIKATIONEN:

-Excellent knowledge of the worldwide pharmacovigilance legislation pertaining to safety signal management and benefit-risk assessment
-Fluent English language skills
-Good bio statistical understanding
-Proven ability to interpret regulatory requirements into practical working models with appropriate documentation

WEITERE QUALIFIKATIONEN:

Drug safety manager