Safety Operations Submission Associate
For our client in pharma industry we are looking for Safety Operations Submission Associate. The Safety Operations Submission Associate role is responsible for daily, compliant availability of Individual Case Safety Reports (ICSRs) for affiliates and health authorities worldwide, ensuring adherence to regulatory requirements and internal procedures. The position operates within the Safety Operations (SO) Centre of Expertise & Submission in Global Patient Safety, contributing to secure global regulatory compliance through timely submission of single safety cases. Core activities include working in the Global Safety database according to written procedures, supporting database users on regulatory reporting requirements related to ICSRs, and collaborating closely with an international Submission team based in Denmark and India. The role requires regular interaction with Safety Operations colleagues, affiliates and other stakeholders to manage submission-related matters and resolve submission failures. Responsibilities also cover contributing to the development and maintenance of submission processes, proactively identifying opportunities for improvement, and participating in knowledge sharing and training efforts to strengthen team performance. Required capabilities include a bachelor’s degree with knowledge of medicinal terminology, experience in pharmacovigilance (preferably with ICSR submission), IT proficiency with databases and web solutions (perferable Argus or Veeva Safety), a structured and detail-oriented approach, a high-quality mindset and adherence to procedures, service orientation, ability to work under shifting priorities and tight deadlines, and fluency in English with the ability to collaborate across cultures and functions.
- Forside
- Ework Group
- Safety Operations Submission Associate
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