Associate Director Signal Management

Job Purpose As the process owner for Signal Management, the Associate Director GlobalSignal Management is responsible for managing and leading a team of externalpartners who identifies and analyzes all safety signals in the Safety Signalmanagement tool for all products and products from partners for which anagreement is in place. Ensures compliance and efficiency of Safety Signal Management activities forour products. Responsible for Safety Training for all employees and acting as subject matterexpert for MedDRA queries Support the development, customization and maintenance of the signal managementtool to ensure it supports all signal detection and management activities in anefficient and effective way. As the global process and business owner for Signal Management, has to: 1. Support the integration of local signal detection and managementrequirements into the global process 2. Define and oversees the long -term strategy to ensure that it maintains itsworld class leading position in automated signal detection and evaluation. 3. Lead and manage a team of external service providers who are accountable fordetecting and analyzing technical signals from post -marketing surveillance inthe signal management tool for all products, our group companies or our partners(for which an agreement is in place) where the global safety database holder. 4. Oversee and ensure maintenance of all our MedDRA Queries which are used byPatient Safety 5. Drive the development and implementation of efficient workflow processes forthe Safety Management Team (SMT). This includes the timely update of BusinessGuidance Documents and SOPs accordingly. 6. Provide strategic leadership and oversight for all signal detection andmanagement activities conducted by the ESP, leveraging internal and externaldatabases. Ensure practices are aligned with regulatory guidance and industrystandards, while continuously tailoring signal management processes accordingto the risk profile of the product portfolio. Proactively monitor the evolvingregulatory landscape to maintain compliance and drive innovation in signalmanagement. 7. Ensure that all new relevant medical safety signals originating from signalreview or analyses from external Health Authority databases are adequatelycommunicated to the respective Safety Lead for further escalation to the SMT. 8. Partner with Safety Leads who present safety signals to various internal andexternal boards 9. Review of Safety Signal sections of License partner agreements. 10. Ensure timely and accurate communications of signals to license partners asper PVA and to PS countries. 11. Support the development and customization of signal detection andmanagement software so to contribute to it is compliance with all applicableregulatory requirements. If required, contribute to linking the tool withappropriate regulatory information, so that its outputs can be used fordownstream activities (e.g. addendum to clinical overview, presentations atSignal Review Team (SRT), SMT, Medical Safety Review Board (MSRB) and ourPorfolio Stewardship Board (SPSB) meetings, aggregate reports). 12. Develop new approaches (including policy, methodology, processimprovements) for signal detection in Safety Signal software. Contribute to thedevelopment and customization of the tool having in mind how it can be used tointegrate AI solutions in the signal management process. 13. Provide expert guidance in the development of all relevant aspects ofsignal detection strategy using post -marketing safety databases. 14. Ensure the signal management tools support the required KPIs for signaldetection and management 15. Have an overall understanding of the processes and software related tosignal management so to ensure processes related to signal management areinterconnected and streamlined as per lean principles. 16. Develop metrics for and ensure compliance with business rules of signalreview and provide a periodic compliance report to Patient Safety leadership. 17. Represent us on external working groups related to Safety SignalManagement. 18. Lead talent -pipeline, onboarding, training and mentoring activities for newmembers. 19. Lead audits and inspections as a SME for Safety Signal Management Requirements Ideal Background Education: Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required. Experience and Skills: At least 6 years' experience in pharmacovigilance operations, including some hands -on experience in performing signal detection and management. Additional hands -on experience in the preparation of aggregate reports, case processing, and risk management plans is a plus. • Excellent understanding ICH GCP, GVP guidelines, local pharmacovigilance regulations and medical terminology • Excellent understanding of signal detection process; understanding on upstream and downstream processes is a plus. • Attention to detail, quality focused and ability to identify process interdependencies • Strong organizational and project management skills • Ability to motivate, direct and foster teamwork, strong negotiation andconflict management. • Ability to develop and maintain effective working relationships withsuperiors and peers. • Ability to operate effectively in an international and matrix environment. • Understanding of signal detection statistical methodology • Excellent communication (written and verbal) and presentation skills • Strong computer skills including, but not limited to, creation ofspreadsheets, templates, presentations and working with and development ofsafety databases/applications/software. • Ability to work independently, under pressure, demonstrating initiative andflexibility through effective innovative leadership ability. • Experience with PV audits and inspections and writing and implementation ofCAPA • Problem solving and strong negotiation and conflict management skills. • Some understanding of how large language models work, knowledge ofregulations on the use of AI in healthcare and, more specifically, inpharmacovigilance (e.g. CIOMS XIV, EU AI act). Languages: Fluency in English. Knowledge of other languagesdesirable.