Beschreibung
I am currently looking for a Freelancer for Signal Management for a well known pharmaceutical company in Hesse, Germany.Freelancer for Signal Management - until the end of 2016 with possible extension - Hesse, Germany
The Tasks:
The signal management process starts with the timely detection of new potential safety signals and ends with the implementation of risk mitigation measures at local level including the monitoring and oversight of the implementation and the assessment of the effectiveness of these. Effective and robust safety signal management is essential to ensure effective safety risk assessment, risk mitigation and appropriate benefit-risk evaluation for products, both during clinical development and post-marketing.
The GDS Process Owner Signal Management & Benefit-Risk Assessment is accountable for: * Development, maintenance and ownership of efficient GDS processes related to signal management, in compliance with legislations and appropriately described in Quality Documents. This includes the process for routine and additional risk mitigation actions including safety communication (e.g. Direct Healthcare Professional Communiation/Dear Investigator Letter), for benefit-risk evaluation and the assessment of effectiveness of risk mitigation actions.
- 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 instructions and guidance to the authors of these documents, both written and verbally on request
- 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
- Implementation and maintenance of a quality control process for the signal management process
- Representation of GDS for matters related to signal management and benefit-risk assessment in Health Authority inspections and company audits; to define and implement corrective and preventive actions for GDS with regard to signal management findings from audits and inspections.
- Excellent knowledge of the worldwide pharmacovigilance legislation pertaining to safety signal management and benefit-risk assessment; awareness of any proposed changes in the legislation, with assessment of the implications of such changes and proactive plans to incorporate these in the processes.
- Understanding of future sources of safety information for safety signal detection and planning to incorporate these sources into our safety signal detection process.
- Delivery of appropriate training to GDS staff with respect to signal management and benefit-risk assessment.
- Monitoring the effectiveness of the processes in place within GDS, and driving continuous improvement and learning from internal best practice and external benchmarks
The requirements:
- Experience with IT signal management algorithms
- Good biostatistical understanding
- Profound pharmaceutical industry experience, in pharmacovigilance and/or regulatory affairs and/or quality assurance, preferably including experience of medical safety evaluation, labeling management, risk management activities, experience of benefit-risk evaluation, regulatory inspections and follow-up actions with CAPA plans
- Proven ability to interpret regulatory requirements into practical working models with appropriate documentation
- Ability to manage multiple situations/issues under time pressure
- Clarity of thinking, with ability to simplify potentially complex issues
- Communication skills including moderation of controversial discussions
- Effective presentation and training skills
- Excellent organizational skills, ability to prioritise work and adapt rapidly to changing priorities
- Proven problem-solving and decision-making skills
Languages:
- English
- German
Keywords: University degree level in bioscience/Master of Science or equivalent education in health care or related life sciences with profound experience in pharmacovigilance
If you are interested do not hesitate to contact me!
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