Pharmaceutical Surveillance Advisor
5 days ago
Our Global Business Services department is responsible for handling case processing from different sources, including spontaneous, literature, solicited, and clinical trials. We also engage in safety report submission, training, Learn It administration, quality control of Individual Case Safety Reports, Argus configuration and maintenance, information technology quality assurance, signal detection activities, risk mitigation activities, training coordination, and literature surveillance activities.
The successful candidate will join a dedicated team of professionals working together to deliver high-quality services and support our business operations.
Responsibilities
* Collaborate with cross-functional teams to establish and maintain product safety profiles during development and maintenance of labeling for marketed products.
* Develop and implement plans to address emerging safety issues related to our products.
* Conduct thorough reviews of adverse event reports and develop recommendations for corrective actions.
* Work closely with regulatory agencies to ensure compliance with all applicable laws and regulations.
Requirements
* Bachelor's degree in a relevant field (e.g., pharmacy, medicine, public health).
* Minimum 5 years of experience in pharmaceutical safety, preferably in a regulatory agency or industry setting.
* Strong understanding of pharmaceutical regulations and guidelines (e.g., ICH E2A, FDA Guidance for Industry).
* Excellent communication and project management skills.
About Us
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We are committed to creating an inclusive culture that celebrates diversity, equity, and inclusion. Our success relies on the joint potential and collaboration of our employees around the world.
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