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Manager Systems Management
Sandoz
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Maintain and manage the reporting requirements system (T-Rex), acting as a super user for end users and a key contact for stakeholders.
- Serve as Business System Owner or Deputy System Owner to deliver global strategic initiatives and solutions for Patient Safety and Pharmacovigilance.
- Coordinate timely submission gateway implementations and submissions of ICSRs to Health Authorities, Country Organizations, and License Partners, adhering to current regulatory standards.
- Lead or contribute to global technical projects, cross-functional workshops, and the development, testing, and validation of Safety Systems/IT applications, including drafting related documentation.
- Oversee tasks outsourced to service vendors, providing necessary guidance and training to ensure effective interaction and compliance.
- Identify compliance gaps or discrepancies in ICSR reporting and propose improvements, while ensuring inspection readiness and supporting Health Authority inspections and internal audits.
- Degree in life science or computing subject
- Fluent in spoken and written English. Understanding of another major European language (French, German, Spanish) preferred
- Minimum of 7 years of experience in drug development, with at least 5 years in safety data management, and expertise in Pharmacovigilance systems and databases
- Thorough understanding of reference data for Pharmacovigilance (e.g., medical dictionaries, product and device definitions)
- Broad and in-depth knowledge of Pharmacovigilance and Drug safety business processes, along with excellent mentoring, coaching skills, and the ability to lead and deliver initiatives.
Employment Type: Full Time, Permanent
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Sandoz Benefits
Competitive compensation Pay equity Pay for sustainable performance Differentiated benefits and wellbeing programs Values & integrity Balanced rewards 
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