Drug Safety Specialist

At Novo Nordisk, our mission is to improve the lives of people living with chronic diseases. As a Drug Safety Specialist, you will play a crucial role in ensuring the safety and efficacy of our life-saving medications. We are looking for a highly motivated and detail-oriented individual to join our team. If you have a passion for patient safety and possess the qualifications and skills listed below, we encourage you to apply for this impactful and rewarding position.

1. Monitor and assess the safety profile of Novo Nordisk's medications, including adverse events, product complaints, and other safety-related information.
2. Collaborate with cross-functional teams to review and analyze safety data, identify potential safety signals, and make appropriate recommendations for risk management.
3. Conduct thorough and timely review of safety reports and documentation, ensuring compliance with regulatory requirements and company policies.
4. Serve as a subject matter expert on drug safety regulations and guidelines, both at the national and international levels.
5. Develop and maintain safety-related documents, such as safety management plans, risk management plans, and safety narratives.
6. Participate in the preparation and submission of regulatory reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Safety Update Reports (SURs).
7. Provide safety input and support for clinical trial protocols, study reports, and other scientific documents.
8. Collaborate with external partners, such as contract research organizations (CROs), to ensure timely and accurate exchange of safety information.
9. Stay updated on industry trends and advancements in drug safety and risk management, and communicate relevant information to internal stakeholders.
10. Contribute to the continuous improvement of drug safety processes and procedures, and participate in departmental initiatives and projects.

According to JobzMall, the average salary range for a Drug Safety Specialist in Paris, France is between €30,000 and €60,000 per year. However, this can vary depending on the specific company, experience level, and other factors.

Novo Nordisk AS engages in the research, development, manufacture, and marketing of pharmaceutical products. It operates through the Diabetes and Obesity Care; and Biopharmaceuticals segments. The Diabetes and Obesity Care segment covers insulins, glucagon-like-peptide 1, other protein-related products, oral anti-diabetic drugs and obesity. The Biopharmaceuticals segment handles the research, development, manufacture, and distribution of products within the areas of haemophilia, growth hormone, hormone replacement, inflammation and other therapy areas.