Safety Operations Specialist I

Department : Global Safety Global Business Services.

Are you passionate about ensuring the safety of medicinal products? Do you have extensive experience in pharmacovigilance and regulatory compliance? If so, you might be the perfect fit for our Safety Operations Specialist I position! Read more and apply today for a life-changing career.

A Safety Operations Specialist I at Novo Nordisk should Establish new or improved methods of working within your field of expertise by sharing best practices and ensuring consistency in safety deliverables. Act as a competent partner to the line of business by providing qualified support in relation to quality, processes, products, organization, and corporate business objectives.

• Handle adverse events and other safety information, ensuring fulfilment of global regulatory requirements.
• Lead projects across functional areas by defining project scope, goals, expected deliverables, and stakeholder mapping.
• Act as a deviation and change request owner, preparing deviation and change reports, facilitating root cause investigations, and driving decision-making on corrective/preventive actions.
• Review safety data presented in relation to audits and inspections, and present global safety processes within C2.01 in global audits and inspections.
• Collaborate with affiliates to support the implementation of new processes and/or requirements based on increased regulatory demands.

• Graduation and/or post-graduation in life sciences.
• Minimum of 6 years of relevant working experience within pharmacovigilance.
• Extensive knowledge of pharmacovigilance principles and business processes required for the efficient handling of safety information.
• Experience in providing training and support in a professional context.
• In-depth understanding of Novo Nordisks organization and/or pharmaceutical company operations.
• Extensive experience in studying scientific regulations/guidelines.
• Extensive knowledge and understanding of GxP requirements.
• Experience working with business process improvements.
• Experience working in international and diverse professional groups.
• Fluency in English, both written and spoken.

Global Safey - Global Business Services (GS-GBS) was set up in 2010 as one of the hubs for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited, and clinical trials.

Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, LearnIt administration, quality control of individual case safety reports (ICSR), ARGUS configuration and maintenance, information technology quality assurance, training coordination, and literature surveillance activities, including medical literature monitoring.