Associate Director – Global Signal Management (m/w/d)
Take part in shaping our signal management process as the Associate Director, responsible for strategic leadership and operational excellence throughout Sandoz and partner products.
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).
Dissatisfied, unchallenged, or eager to discover something new?
What are you waiting for? Apply now, unlock your potential, and aim for greater satisfaction in your career. I’m here to support you with my expertise and guide you through the entire application process. I look forward to meeting you and am excited to hear your story!
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