Pharmacovigilance Specialist

Are you passionate about patient safety and ensuring the quality of pharmaceutical products? Do you have a strong attention to detail and an analytical mindset? Novo Nordisk is seeking a highly motivated Pharmacovigilance Specialist to join our team and help us promote the safe use of our products worldwide.In this role, you will play a crucial part in monitoring and evaluating the safety of our pharmaceutical products, ensuring compliance with regulations and guidelines. You will collaborate with cross-functional teams, communicate with regulatory authorities, and contribute to the continuous improvement of our pharmacovigilance processes.To excel in this position, you must hold a degree in Pharmacy, Medicine, or a related field, with at least 2-3 years of experience in pharmacovigilance. Your excellent communication and problem-solving skills, as well as your ability to work independently, will be key to your success.If you are ready to make a positive impact on patients' lives and contribute to the success of a leading global healthcare company, we encourage you to apply for this exciting opportunity. Join us at Novo Nordisk and be a part of our mission to drive change and improve the lives of millions living with chronic diseases.

1. Monitor and evaluate the safety of pharmaceutical products and report any adverse events or safety concerns to relevant internal and external stakeholders.
2. Ensure compliance with global pharmacovigilance regulations and guidelines, including but not limited to FDA, EMA, and ICH.
3. Collaborate with cross-functional teams, such as medical affairs, regulatory affairs, and quality assurance, to ensure timely and accurate reporting of safety information.
4. Conduct thorough and timely signal detection activities, including reviewing literature, analyzing safety data, and identifying emerging safety concerns.
5. Communicate with regulatory authorities, including preparing and submitting safety reports and responding to inquiries, as needed.
6. Contribute to the continuous improvement of pharmacovigilance processes, including developing and implementing new procedures and systems.
7. Participate in the review and assessment of clinical trial protocols, study reports, and other relevant documents to ensure proper safety reporting.
8. Keep up-to-date with the latest pharmacovigilance regulations and guidelines, and provide relevant training to colleagues as needed.
9. Maintain accurate and complete documentation of all pharmacovigilance activities.
10. Work independently to manage and prioritize multiple tasks, taking into consideration timelines, resources, and potential risks.
11. Use analytical skills and critical thinking to identify potential issues and propose solutions to improve patient safety and product quality.
12. Represent the company in a professional manner, both internally and externally, and promote the importance of pharmacovigilance and patient safety.
13. Support the company's mission and values by promoting a culture of patient-centricity and continuous improvement.
14. Provide guidance and support to colleagues in pharmacovigilance and other departments as needed.
15. Participate in relevant internal and external meetings, conferences, and training programs to stay updated on industry trends and best practices in pharmacovigilance.

According to JobzMall, the average salary range for a Pharmacovigilance Specialist in Dallas, TX, USA is between $78,000 and $110,000 per year. This range can vary depending on the individual's level of experience, education, and specific job responsibilities. Some factors that can also affect the salary range include the size and type of the company, the location within Dallas, and the demand for pharmacovigilance specialists in the area.

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.