Associate Director Signal Management

Job Purpose 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 our products. Responsible for Safety Training for all employees and acting as subject matter expert for MedDRA queries. Support 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. Responsibilities Support the integration of local signal detection and management requirements into the global process. Define and oversee the long‑term strategy to ensure the signal management approach maintains a world‑class 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, our group companies or partners (for which an agreement is in place) where the global safety database is held. Oversee and ensure maintenance of all MedDRA queries which are used by Patient Safety. Drive the development and implementation of efficient workflow processes for the Safety Management Team (SMT), including the timely update of Business Guidance Documents and SOPs accordingly. Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP, leveraging internal and external databases, ensuring 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. Ensure that all relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for escalation to the SMT. Partner with Safety Leads who present safety signals to various internal and external boards. Review safety signal sections of license partner agreements. Ensure timely and accurate communications of signals to license partners as per PVA and to PS countries. Support the development and customization of signal detection and management software to ensure compliance with all applicable regulatory requirements. If required, contribute to linking the tool with appropriate regulatory information so that its outputs can be used for downstream activities (e.g., addendum to clinical overview, presentation at Signal Review Team (SRT), SMT, Medical Safety Review Board (MSRB), and Portfolio Stewardship Board (SPSB) meetings, aggregate reports). Develop new approaches (including policy, methodology, process improvements) for signal detection in the safety signal software. Contribute to the tool’s customization with an eye toward integrating AI solutions in the signal management process. Provide expert guidance in developing all relevant aspects of the signal detection strategy using post‑marketing safety databases. 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 per 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 an 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 of ICH GCP, GVP guidelines, local pharmacovigilance regulations and medical terminology. Excellent understanding of signal detection processes; understanding upstream and downstream processes is a plus. Attention to detail, quality focus, and ability to identify process interdependencies. Strong organizational and project management skills. Ability to motivate, direct, and foster teamwork, with strong negotiation and conflict management. Ability to develop and maintain effective working relationships with superiors 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 of spreadsheets, templates, presentations and working with and developing safety databases / applications / software. Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership. Experience with PV audits and inspections, and writing and implementation of CAPA. Problem solving and strong negotiation and conflict management skills. Some understanding of how large language models work, knowledge of regulations on the use of AI in healthcare and, more specifically, in pharmacovigilance (e.g., CIOMS XIV, EU AI Act). Languages : Fluency in English. Knowledge of other languages desirable. Additional Requirements Responsible for overseeing the strategy, governance, and quality of all master data (Vendors, Customers, Materials), ensuring its accuracy, consistency, and alignment with business processes across the organization. Requirements: 10+ years of experience in global data management; in depth knowledge in Master Data Governance and Strategy; expertise in Data Quality Management; knowledge in Data Integration and Architecture Change Management and Data Migration. #J-18808-Ljbffr