Drug Safety Specialist

Welcome to Novo Nordisk, a global healthcare company with a passion for improving the lives of patients around the world. We are currently seeking a dedicated Drug Safety Specialist to join our team and help us ensure the safety and effectiveness of our pharmaceutical products. As a Drug Safety Specialist, you will play a critical role in monitoring and evaluating the safety data of our drugs, and collaborating with various departments to ensure compliance with regulatory requirements. This position requires a detail-oriented and analytical individual with a strong understanding of pharmacovigilance principles and regulations. If you are passionate about patient safety and have the necessary qualifications, we would love to hear from you. Join us in our mission to make a difference in the lives of patients and contribute to the advancement of healthcare.

1. Monitor and evaluate the safety data of all pharmaceutical products produced by Novo Nordisk, in accordance with global regulatory requirements and company policies.
2. Collaborate with cross-functional teams to ensure timely and accurate submission of safety reports to regulatory authorities.
3. Conduct thorough review and analysis of adverse event reports, and escalate any potential safety concerns to the appropriate team members.
4. Maintain a thorough understanding of pharmacovigilance principles, regulations, and guidelines to ensure compliance in all aspects of drug safety.
5. Assist in the development and implementation of drug safety processes and procedures to ensure continuous improvement in safety monitoring and reporting.
6. Serve as a subject matter expert on drug safety matters, providing guidance and support to internal teams and external partners as needed.
7. Participate in safety signal detection activities and contribute to risk management plans for Novo Nordisk products.
8. Conduct periodic safety data review and prepare periodic safety reports for regulatory submissions.
9. Assist with the preparation and maintenance of drug safety related documentation, including standard operating procedures, work instructions, and training materials.
10. Keep up-to-date with industry developments and changes in regulatory requirements related to drug safety, and proactively communicate any potential impact to the team.
11. Act as a liaison between Novo Nordisk and external stakeholders, including regulatory authorities and other industry organizations, on drug safety matters.
12. Adhere to all company policies and procedures, and ensure that all drug safety activities are conducted in compliance with applicable laws and regulations.
13. Uphold Novo Nordisk's commitment to patient safety and contribute to the company's mission of improving the lives of patients worldwide.

According to JobzMall, the average salary range for a Drug Safety Specialist in Munich, Germany is between €60,000 and €80,000 per year. This may vary depending on experience, education, and the specific company or industry the specialist is working in.

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.