The Associate Director, Global Signal Management, is responsible for leading and managing the global Signal Management process for all Sandoz products and relevant partner products. This includes overseeing the detection, analysis, and communication of safety signals, ensuring compliance with regulatory requirements and industry standards, and driving process efficiency and and mentoring team members, and acting as a subject matter expert in signal detection methodologies and safety database management. The Associate Director ensures that the signal management process and tools support effective risk detection, evaluation, and reporting across the product portfolio.
Project title:
Associate Director Signal Management 100% m/w/d
Type of employment:
Payroll
Industry:
Pharma
Skills:
Pharmacovigilance
Project start:
Project duration:
Location:
Basel, Schweiz
Key Responsibilities:
* Lead and manage external service providers responsible for signal detection and analysis in post-marketing surveillance.
* Oversee and maintain MedDRA queries and ensure alignment with Patient Safety requirements.
* Develop, implement, and optimize workflows, SOPs, and business guidance documents for the Safety Management Team (SMT).
* Ensure timely communication of new safety signals to Safety Leads and license partners, in line with regulatory and contractual requirements.
* Support the development, customization, and maintenance of signal management software, including integration of AI solutions where applicable.
* Provide expert guidance on signal detection strategy and methodologies, leveraging internal and external safety databases.
* Monitor regulatory changes and ensure the signal management process remains compliant and innovative.
* Represent in external working groups related to Safety Signal Management.
* Lead audits, inspections, and CAPA related to signal management as subject matter expert.
* Drive talent development, including onboarding, training, and mentoring of team members.
* Develop and track KPIs and metrics to monitor compliance and process performance.
Qualifications:
* Bachelor's degree in Pharmacy, Nursing, PharmD, PhD, or Medical degree (MBBS/MD) required.
* Minimum 6 years' experience in pharmacovigilance operations, including hands-on signal detection and management. Experience with aggregate reports, case processing, or risk management plans is a plus.
* Deep understanding of ICH GCP, GVP, local pharmacovigilance regulations, and medical terminology.
* Knowledge of signal detection processes, upstream and downstream pharmacovigilance processes.
* Strong organizational, project management, and leadership skills, with the ability to operate effectively in a global matrix environment.
* Excellent communication, presentation, and interpersonal skills.
* Proficiency with safety databases, applications, software, and analytical tools.
* Experience with PV audits, inspections, and CAPA development.
* Understanding of statistical methods for signal detection.
* Awareness of AI applications in pharmacovigilance and relevant regulatory frameworks (e.g., CIOMS XIV, EU AI Act).