Description
We are looking for a
Signal Manager (m/f)
Reference: -en
Start: asap
Duration: 3 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Drug safety manager