
Drug Safety Specialist
Are you passionate about ensuring the safety and well-being of patients? Do you have a strong attention to detail and a background in healthcare or pharmaceuticals? Novo Nordisk is seeking a dedicated and driven Drug Safety Specialist to join our team. As a global leader in diabetes care and other chronic diseases, Novo Nordisk is committed to maintaining the highest standards of drug safety. In this role, you will play a crucial part in our mission to improve the lives of millions of patients worldwide. If you have a strong understanding of pharmacovigilance principles and regulations, along with excellent communication and analytical skills, we encourage you to apply for this exciting opportunity.
- Monitor and evaluate adverse event reports for products within Novo Nordisk's portfolio to ensure compliance with pharmacovigilance regulations and guidelines.
- Collaborate with cross-functional teams to assess and manage risks associated with Novo Nordisk products.
- Conduct thorough investigations into adverse event reports, including reviewing medical records and contacting healthcare professionals for additional information.
- Maintain accurate and up-to-date documentation of all adverse event reports and related activities.
- Communicate with regulatory authorities and other stakeholders regarding adverse event reports and safety concerns.
- Support the development and implementation of drug safety strategies and risk management plans.
- Stay current with pharmacovigilance regulations and guidelines to ensure compliance and provide recommendations for process improvements.
- Assist in the preparation and submission of safety reports to regulatory agencies.
- Provide training and guidance to colleagues on drug safety processes and procedures.
- Participate in cross-functional meetings and provide input on safety-related matters.
- Contribute to the continuous improvement of drug safety processes and systems.
- Ensure timely reporting of safety information to regulatory authorities.
- Conduct signal detection activities and review safety data to identify potential safety issues.
- Collaborate with internal and external stakeholders to ensure safety data is collected and reported accurately.
- Support risk management activities for Novo Nordisk products throughout their lifecycle.
- Adhere to all relevant company policies, procedures, and guidelines.
Bachelor's Degree In Pharmacy, Pharmacology, Or Related Field
Minimum Of 2 Years Experience In Pharmacovigilance Or Drug Safety
Strong Knowledge Of Fda Regulations And International Drug Safety Guidelines
Proficiency In Data Analysis And Adverse Event Reporting Systems
Excellent Communication And Collaboration Skills To Work With Cross-Functional Teams And External Stakeholders.
Quality Assurance
Data Analysis
Reporting
Case management
Risk assessment
Regulatory compliance
Medical coding
Drug Safety
Pharmacovigilance
Signal Detection
Adverse Events
Communication
Conflict Resolution
Customer Service
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Drug Safety Specialist in Princeton, NJ, USA is $70,000 - $100,000 per year. This can vary depending on the specific company, years of experience, and education level of the individual.
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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.

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