Are you passionate about ensuring the safety of medicinal products? Do you have extensive experience in pharmacovigilance and regulatory compliance? If so, this is the perfect opportunity for you to make a life-changing impact! Join Novo Nordisk as a Safety Operations Specialist I and be part of a global team that drives the safety of healthcare products.
The Position
As a Safety Operations Specialist I, you will play a key role in ensuring the safety of medicinal products. You will establish new or improved methods of working within your field, sharing best practices, and ensuring consistency in safety deliverables. You will provide qualified support to the line of business on quality, processes, products, and corporate objectives.
Key Responsibilities:
- Handle adverse events and other safety information, ensuring compliance with global regulatory requirements.
- Lead cross-functional projects by defining scope, goals, expected deliverables, and stakeholder mapping.
- Act as the owner for deviations and change requests, preparing reports, facilitating root cause investigations, and making decisions on corrective/preventive actions.
- Review safety data for audits and inspections, presenting global safety processes during these events.
- Collaborate with affiliates to implement new processes and address increased regulatory demands.
Qualifications
- Education: Graduation and/or post-graduation in life sciences.
- Experience: Minimum of 6 years of relevant experience in pharmacovigilance.
- Skills:
- Extensive knowledge of pharmacovigilance principles and business processes.
- Experience in providing training and professional support.
- In-depth understanding of Novo Nordisk’s operations or pharmaceutical industry standards.
- Strong knowledge of scientific regulations/guidelines and GxP requirements.
- Experience in business process improvements and working in international teams.
- Fluency in English (both written and spoken).
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