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von: Manpower
Manpower
As the process owner for Signal Management, the Associate Director Global Signal Management is responsible for managing and leading a team of external partners who identify and analyze all safety signals in the Safety Signal Management tool for all products and products from partners for which an agreement is in place.
Ensures compliance and efficiency of Safety Signal Management activities for all products.
Responsible for training safety employees and acting as subject matter expert for MedDRA queries.
Supports the development, customization, and maintenance of the signal management tool to ensure it supports all signal detection and management activities in an efficient and effective way.
As the global process and business owner for Signal Management, this role has to:
Support the integration of local signal detection and management requirements into the global process.
Define and oversee the long-term strategy to ensure the organization maintains its leading position in automated signal detection and evaluation.
Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post-marketing surveillance in the signal management tool for all products, group companies, or partners (for which an agreement is in place) where the organization is the global safety database holder.
Oversee and ensure maintenance of all MedDRA Queries used by Patient Safety.
Drive the development and implementation of efficient workflow processes for the Safety Management Team (SMT). Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP, leveraging internal and external databases. Ensure practices are aligned with regulatory guidance and industry standards, while continuously tailoring signal management processes according to the risk profile of the product portfolio. Proactively monitor the evolving regulatory landscape to maintain compliance and drive innovation in signal management.
Ensure that all new relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further escalation to the SMT.
Partner with Safety Leads who present safety signals to various internal and external boards.
Support the development and customization of signal detection and management software to ensure compliance with all applicable regulatory requirements. Develop new approaches (including policy, methodology, and process improvements) for signal detection in Safety Signal software. Contribute to the development and customization of the tool with a view to integrating AI solutions in the signal management process.
Ensure the signal management tools support the required KPIs for signal detection and management.
Have an overall understanding of the processes and software related to signal management to ensure processes are interconnected and streamlined according to lean principles.
Develop metrics for and ensure compliance with business rules of signal review and provide a periodic compliance report to Patient Safety leadership.
Represent the organization on external working groups related to Safety Signal Management.
Lead talent-pipeline, onboarding, training, and mentoring activities for new members.
Lead audits and inspections as a Subject Matter Expert (SME) for Safety Signal Management.
Bachelor of Science in Pharmacy /Bachelor of Science in Nursing /
PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required.
Fluency in English. and management. of aggregate reports, case processing, and risk management plans is
Attention to detail, quality focused and ability to identify process
Strong organizational and project management skills
? Ability to motivate, direct and foster teamwork, strong negotiation and conflict management.
? Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with and development of safety databases/applications/software.
? Problem solving and strong negotiation and conflict management skills.
? Forschung und Entwicklung
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