Drug Safety Specialist

Novo Nordisk is seeking a highly motivated and detail-oriented individual to join our team as a Drug Safety Specialist. As a global healthcare company dedicated to improving the lives of patients with chronic diseases, we are committed to ensuring the safety of our products. In this role, you will play a critical role in monitoring and evaluating the safety of our drugs, contributing to the development of new treatments, and ensuring compliance with regulatory requirements. We are looking for someone with a strong scientific background, excellent communication skills, and a passion for making a positive impact on patient safety. If you are ready to make a difference and join a dynamic team, we encourage you to apply for this exciting opportunity.

1. Conduct ongoing monitoring and evaluation of safety data for assigned drugs, including adverse event reporting and signal detection.
2. Collaborate with cross-functional teams to contribute to the development and approval of new treatments.
3. Ensure compliance with global regulatory requirements and guidelines related to drug safety.
4. Prepare and submit safety reports to regulatory agencies, including periodic and expedited reports.
5. Serve as a subject matter expert on drug safety for internal and external stakeholders.
6. Conduct safety data analysis and provide recommendations for risk management and mitigation strategies.
7. Participate in safety surveillance activities, including review of safety data from clinical trials and post-marketing sources.
8. Communicate safety findings and recommendations to relevant teams and management.
9. Review and assess safety data from literature and other external sources.
10. Maintain accurate and thorough documentation of safety data and activities.
11. Collaborate with pharmacovigilance vendors and ensure their compliance with company standards and procedures.
12. Stay updated with current pharmacovigilance regulations and industry trends to ensure adherence to best practices.
13. Serve as a point of contact for safety-related inquiries and escalations.
14. Support safety-related audits and inspections.
15. Contribute to the continuous improvement of drug safety processes and procedures.

According to JobzMall, the average salary range for a Drug Safety Specialist in Los Angeles, CA, USA is $72,000-$105,000 per year. This may vary depending on factors such as the specific company, level of experience, and education of the individual.

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.