Associate Director – Global Signal Management

Associate Director – Global Signal Management (m / w / d) Purpose of the Role As the global process owner for Signal Management, you will lead a team of external partners responsible for identifying and analyzing all safety signals for Sandoz products, as well as for partner products covered by agreements. You ensure compliance, quality, and efficiency across all signal management activities, while also acting as subject matter expert (SME) for MedDRA queries and providing training to Sandoz Safety staff. Additionally, you will drive the development, optimization, and maintenance of the global signal management tool, ensuring it supports effective and compliant signal detection and evaluation processes. Key Responsibilities Integrate local signal detection and management requirements into the global process. Define and execute a long‑term strategy to maintain Sandoz’s leading position in automated signal detection and evaluation. Lead and oversee external service providers responsible for identifying and analyzing post‑marketing safety signals for all Sandoz and partner products. Ensure maintenance and continuous improvement of all MedDRA queries used by Patient Safety. Develop and implement efficient workflows for the Safety Management Team, including regular updates of SOPs and business guidance documents. Provide strategic leadership and ensure all signal management activities align with regulatory expectations and industry standards. Ensure timely communication of new or emerging safety signals to the relevant Safety Leads for further escalation. Collaborate closely with Safety Leads presenting signals to internal and external governance boards. Review and oversee the signal management components of partner and license agreements. Guarantee timely communication of safety signals to license partners and Sandoz affiliates in accordance with PVAs. Contribute to the enhancement of the signal detection and management software, including integration of regulatory data and AI‑driven solutions. Develop innovative methods, policies, and process improvements for signal detection within the Safety Signal software. Establish and track key performance indicators (KPIs) to monitor signal management effectiveness. Ensure streamlined and interconnected signal management processes aligned with lean principles. Provide regular compliance reporting to leadership and act as SME during audits and inspections. Represent Sandoz in external working groups and professional forums related to signal management. Lead talent development, onboarding, and mentoring initiatives for new team members. Your Profile Education Bachelor’s or advanced degree (Pharmacy, Nursing, Medicine – MBBS / MD, PharmD, or PhD in a relevant field). Languages Fluent English (written and spoken); additional languages are an advantage. Experience & Skills Minimum of 6 years’ experience in pharmacovigilance operations, including hands‑on signal detection and management. Experience in aggregate reporting, case processing, and risk management planning is an asset. In-depth understanding of ICH GCP, GVP, local pharmacovigilance regulations, and medical terminology. Strong grasp of signal detection processes and related upstream / downstream workflows. Exceptional attention to detail and ability to identify process interdependencies. Strong project management and organizational skills. Proven ability to lead, motivate, and foster teamwork in an international matrix environment. Knowledge of statistical methods for signal detection. Excellent written and verbal communication, including presentation skills. Proficiency with data management tools, templates, and safety databases or applications. Experience with PV audits, inspections, and CAPA implementation. Problem‑solving mindset and flexible, independent working style. Basic understanding of large language models (LLMs) and relevant AI regulations (e.g., CIOMS XIV, EU AI Act). #J-18808-Ljbffr